Sickle Cell DiseasePhase 4NCT02222246
Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
A Phase 4 study testing Hydromorphone (Standardized, weight-based dosing), Morphine Sulfate (Standardized, weight-based dosing) and Hydromorphone (Patient Specific dosing) in people with Sickle Cell Disease, run by Duke University at 2 sites in United States.
Trial summary
The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Hydromorphone (Standardized, weight-based dosing), Morphine Sulfate (Standardized, weight-based dosing) and Hydromorphone (Patient Specific dosing)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2015to 30 Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult SCD patients with genotypes SS, SC, SB+, or SB-
Who cannot join
- Patients with sickle cell trait
- Allergic to both morphine sulfate and hydromorphone,
- Patients who have an explicit care plan that states they cannot be admitted to the hospital for pain control,
- Non-English speaking,
- Patients admitted for a medical complication,
- Record of >24 ED visits in the prior 12 months,
- Children
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Mount Sinai Hospital
New York, New York, 10029
About this study
The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most common reason for SCD patients to visit the ED. Currently, there is no standard approach to managing VOC pain in the ED that is widely accepted and used, and pain management for vaso-occlusive crisis in persons with SCD is very different between providers and not based on research. Many times, patients who come to the ED with sickle cell pain feel that they do not receive adequate pain control. If EDs could provide efficient, effective, safe, patient-centered analgesic management, it may be possible to improve pain management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of the National Institutes of Health. These guidelines recommend patient-specific pain treatment protocols or a standardized pain management protocol for SCD when a patient does not already have a pain treatment protocol designed for them. The purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell disease, and to determine if a large randomized controlled trial is feasible and required.
Read the detailed description
In August 2012 the National Heart, Lung, and Blood Institute (NHBLI) released for public comment their "Management of Sickle Cell Disease" evidence-based recommendations that were developed with consensus panel expertise. Because of a lack of empirical data, most of the recommendations specific to vaso-occlusive crises (VOC) were based on consensus panel expertise. Recommendations included the use of a patient-specific protocol (specific agents and doses for an individual patient). While many attempts have been made to implement patient-specific analgesic protocols for use in emergency departments (EDs), anecdotally, these have been difficult to implement and maintain over time; a practical approach to development, implementation, and dissemination has not been determined. As patient-specific protocols are not available in most EDs, the guidelines go on to recommend a SCD specific standard analgesic protocol. Both of these recommended protocols provide more aggressive VOC pain management than a typical generic ED pain protocol. However, there is an urgent need to rigorously test the NHLBI recommendations and compare the two approaches for managing VOC in the ED. A large randomized clinical trial (RCT) is essential to test these protocols.
This pilot project will compare these two different, evidence-based, protocols which include opioid pain medicines routinely used as standard of care to treat VOC pain in the ED for individuals with SCD, and collect the data necessary to determine if a large RCT is feasible and required. This study is novel in that it will design an approach to develop and implement patient-specific and standard analgesic VOC protocols for use in the ED, will develop a bundle of information technology and education interventions to enhance protocol adoption for the pilot RCT, and also be the first RCT conducted in an ED setting to compare two different ED pain management protocols for SCD patients who experience a VOC.
The study consists of 3 aims:
- Develop and implement patient specific VOC protocols for patients randomized to this arm,
- Conduct a pilot RCT to determine the necessary sample size needed for a large RCT to compare the difference in reduction in pain score from ED arrival to discharge, hospitalization, clinical and safety outcomes, between subjects assigned randomly to either a standard SCD analgesic protocol or to a patient-specific analgesic protocol,
- Measure feasibility of methods and acceptability of and fidelity to protocols by evaluating optimal recruitment and retention strategies, and assessing ED providers perceptions of facilitators and barriers to protocol use and protocol adherence.
The soon to be published NHBLI guidelines for managing SCD will be used as the standard protocol with the modification of basing the initial dose of pain medicine on patient weight. The standard protocol will recommend re-assessment, and re-dosing with possible dose escalation, every 20-30 minutes. Repeat doses for patients randomized to the weight-based protocol, when necessary, will be maintained or provided at 1 dose level increase (no more than 25%) above the initial dose. For patients randomized to the patient -specific protocol, the SCD provider has experience with the individual patient and is best qualified to make dosing and frequency recommendations based upon doses required during past ED and hospital visits for treatment of VOC, and on daily opioid use if applicable. There is no set maximum dose for patients randomized to the patient-specific protocols.
Both the patient-specific and standard protocols will be available in the ED via a patient's electronic medical record. Upon ED arrival, providers will retrieve the patient's study protocol (patient-specific, or standard) which will include the starting agents, and doses, the subsequent analgesic recommendations, and order medications according to the pre-determined protocol.
The study will be conducted at the emergency departments of the University of Cincinnati Medical Center and the Mt. Sinai Hospital in New York. Patients will be enrolled in the study for up to 12-months, but may contribute no more that five different ED visits for VOC pain control during enrollment to allow for a larger number of different patients.
Study outcomes will be compared between ED visits of patients randomized to a patient-specific vs. a standard SCD protocol. The primary outcome will be the difference in pain score from ED arrival to discharge, up to 6 hours, as measured using a visual analogue scale. The trajectories of average pain scores from immediately prior to administration of 1st analgesic dose to discharge by 30 minute increments for each treatment group will also be calculated.
- Conditions
- Sickle Cell Disease
- Being tested
- Hydromorphone (Standardized, weight-based dosing), Morphine Sulfate (Standardized, weight-based dosing), Hydromorphone (Patient Specific dosing), Morphine Sulfate (Patient Specific dosing)
- Keywords
- Sickle Cell Disease, Emergency Department, Vaso-occlusive Crisis, Pain Management, Pilot Project
- Medical subject headings
- Anemia, Sickle Cell, Emergencies, Vaso-Occlusive Crises, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone (Standardized, weight-based dosing)Drug
Also called Dilaudid
Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing)Drug
Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Hydromorphone (Patient Specific dosing)Drug
Also called Dilaudid
Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing)Drug
Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
| Study group | Role | What they receive |
|---|---|---|
| Patient Specific dose of Morphine Sulfate or Hydromorphone | Experimental | A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 5 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history. Receives: Drug: Hydromorphone (Patient Specific dosing); Drug: Morphine Sulfate (Patient Specific dosing) |
| Standard dose of Morphine Sulfate or Hydromorphone | Active comparator | A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose. Receives: Drug: Hydromorphone (Standardized, weight-based dosing); Drug: Morphine Sulfate (Standardized, weight-based dosing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Pain Score as Measured by a Visual Analogue Scale (VAS)
Each ED study visit was the unit of analysis for the statistical methods addressing the primary outcome. The primary outcome was change in pain score from arrival to discharge. Pain severity was assessed at arrival and discharge from ED using a 100 mm visual analogue scale (VAS). The VAS range is 0 to 100 with 0 indicating "no pain" and 100 indicating "pain as bad as it could be" or "worst imaginable pain".Discharge was defined by which one of the following occurred first: (a) decision to admit to hospital; (b) patient physically leaves the ED to home; or (c) after six hours of observation in the ED. Thus, the difference in pain scores were calculated as the arrival minus discharge VAS scores, with higher positive pain difference or change scores indicating greater pain reduction.
Measured: Arrival in ED to discharge from the ED, up to 6 hours
Secondary outcomes (11)
Change in Pain Visual Analogue Scale (VAS) Scores Over Time
Pain severity was assessed at arrival and every 30 minutes until discharge from the ED using a 100 mm visual analogue scale (VAS). The VAS range is 0 to 100 with 0 indicating "no pain" and 100 indicating "pain as bad as it could be" or "worst imaginable pain". Discharge was defined by which one of the following occurred first: (a) decision to admit to hospital; (b) patient physically leaves the ED to home; or (c) after six hours of observation in the ED.
A hierarchical random coefficients regression model for repeated measurements (type of mixed hierarchical mixed-effect model) was conducted on the pain scores collected at six time points (arrival, post-placement 30-min, 60-min, 90-min,120-min, discharge) to evaluate the trajectory of change in pain. Discharge occurred at 120 minutes or later during each visit, with the exception of one discharge at 54 minutes.
Measured: Every 30 minutes from arrival in ED to discharge from the ED, up to 6 hours
Incidence of Nausea During Emergency Department Visits
Nausea at any point from placement until discharge, based on nausea data collected every 30 minutes during that time period. Thus, a nausea variable was derived in which 0=no and 1=yes that nausea was reported by the patient at least once during the placement to discharge time interval.
Measured: From placement in Emergency Department (ED) treatment room to discharge from the ED, up to 6 hours
Incidence of Vomiting During Emergency Department Visits
Vomiting at any point from placement until discharge, based on vomiting data collected every 30 minutes during that time period. Thus, a vomiting variable was derived in which 0=no and 1=yes that vomiting was reported by the patient at least once during the placement to discharge time interval.
Measured: From placement in ED treatment room to discharge from the ED, up to 6 hours
Incidence of a Decrease in Systolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit
Decrease in systolic blood pressure at any point from placement until discharge, based on blood pressure data collected every 30 minutes during that time period. A systolic variable was derived in which 0=no and 1=yes that a >= 20% decrease of baseline systolic blood pressure was reported by the patient at least once during the placement to discharge time interval.
Measured: From placement in ED treatment room to discharge from the ED, up to 6 hours
Incidence of a Decrease in Diastolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit
Decrease in diastolic blood pressure at any point from placement until discharge, based on blood pressure data collected every 30 minutes during that time period. A diastolic variable was derived in which 0=no and 1=yes that a > 20% decrease of baseline diastolic blood pressure was reported by the patient at least once during the placement to discharge time interval.
Measured: From placement in ED treatment room to discharge from the ED, up to 6 hours
Incidence of Oxygen Desaturation (< 95%) (YES) During Emergency Department Visit
Saturation of peripheral capillary oxygen < 95% (SPO2 < 95%) at any point from placement until discharge, based on SPO2 data collected every 30 minutes during that time period. Thus, a SPO2 variable was derived in which 0=no and 1=yes that SPO2 < 95% was reported by the patient at least once during the placement to discharge time interval.
Measured: From placement in ED treatment room to discharge from the ED, up to 6 hours
Incidence of Respiratory Distress (YES) During Emergency Department Visit
Respiratory distress at any point from placement until discharge, based on data collected every 30 minutes during that time period. Thus, a respiratory distress variable was derived in which 0=no and 1=yes that respiratory distress was reported by the patient at least once during the placement to discharge time interval.
Measured: From placement in ED treatment room to discharge from the ED, up to 6 hours
Incidence of Sedation During Emergency Department Visit
Severe-to moderate sedation at any point from placement until discharge, based on sedation data collected every 30 minutes during that time period. Thus, a sedation variable was derived in which 0=no and 1=yes that moderate-severe sedation was reported by the patient at least once during the placement to discharge time interval. Sedations scoring was as follows: None was defined as "awake and alert", Mild sedation was defined as "responds to voice", Moderate sedation was defined as "responds to touch, with or without voice" and Severe sedation was defined as "somnolent, difficult to arouse".
Measured: From placement in ED treatment room to discharge from the ED, up to 6 hours
Incidence of the Need for Supplemental Oxygen During Emergency Department Visit
Need for supplemental oxygen during the Emergency Department stay; this was determined at discharge.
Measured: Following the initiation of opioid therapy until discharge from the ED, up to 6 hours
Incidence of the Administration of Naloxone During Emergency Department Visit
Naloxone administered during the Emergency Department stay; this was determined at discharge.
Measured: Following the initiation of opioid therapy until discharge from the ED, up to 6 hours
Incidence of the Need for Assistive Ventilation
Intubation or other assistive ventilation techniques - including bag, valve, or mask was performed during the ED stay; this was determined at discharge.
Measured: Following the initiation of opioid therapy until discharge from the ED, up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study start15 Mar 2015
- Primary completion31 May 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), University of Cincinnati, Mount Sinai Hospital, New York
- Responsible party
- Sponsor
- Investigators
- Paula Tanabe, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222246
- Sponsor's protocol ID
- Pro00054047
- Other IDs
- R34 RHL121224A
- Status last verified
- Jun 2017
- First submitted
- 19 Aug 2014
- Last updated
- 4 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02222246
- Acronym / sponsor ID
- Pro00054047
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Emergency Department, Vaso-occlusive Crisis, Pain Management, Pilot Project
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), University of Cincinnati, Mount Sinai Hospital, New York
- Study start
- 15 Mar 2015 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 21 Aug 2014 (estimated)
- Results
- Posted 4 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most common reason for SCD patients to visit the ED. Currently, there is no standard approach to managing VOC pain in the ED that is widely accepted and used, and pain management for vaso-occlusive crisis in persons with SCD is very different between providers and not based on research. Many times, patients who come to the ED with sickle cell pain feel that they do not receive adequate pain control. If EDs could provide efficient, effective, safe, patient-centered analgesic management, it may be possible to improve pain management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of the National Institutes of Health. These guidelines recommend patient-specific pain treatment protocols or a standardized pain management protocol for SCD when a patient does not already have a pain treatment protocol designed for them. The purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell disease, and to determine if a large randomized controlled trial is feasible and required.
Detailed description
In August 2012 the National Heart, Lung, and Blood Institute (NHBLI) released for public comment their "Management of Sickle Cell Disease" evidence-based recommendations that were developed with consensus panel expertise. Because of a lack of empirical data, most of the recommendations specific to vaso-occlusive crises (VOC) were based on consensus panel expertise. Recommendations included the use of a patient-specific protocol (specific agents and doses for an individual patient). While many attempts have been made to implement patient-specific analgesic protocols for use in emergency departments (EDs), anecdotally, these have been difficult to implement and maintain over time; a practical approach to development, implementation, and dissemination has not been determined. As patient-specific protocols are not available in most EDs, the guidelines go on to recommend a SCD specific standard analgesic protocol. Both of these recommended protocols provide more aggressive VOC pain management than a typical generic ED pain protocol. However, there is an urgent need to rigorously test the NHLBI recommendations and compare the two approaches for managing VOC in the ED. A large randomized clinical trial (RCT) is essential to test these protocols.
This pilot project will compare these two different, evidence-based, protocols which include opioid pain medicines routinely used as standard of care to treat VOC pain in the ED for individuals with SCD, and collect the data necessary to determine if a large RCT is feasible and required. This study is novel in that it will design an approach to develop and implement patient-specific and standard analgesic VOC protocols for use in the ED, will develop a bundle of information technology and education interventions to enhance protocol adoption for the pilot RCT, and also be the first RCT conducted in an ED setting to compare two different ED pain management protocols for SCD patients who experience a VOC.
The study consists of 3 aims:
- Develop and implement patient specific VOC protocols for patients randomized to this arm,
- Conduct a pilot RCT to determine the necessary sample size needed for a large RCT to compare the difference in reduction in pain score from ED arrival to discharge, hospitalization, clinical and safety outcomes, between subjects assigned randomly to either a standard SCD analgesic protocol or to a patient-specific analgesic protocol,
- Measure feasibility of methods and acceptability of and fidelity to protocols by evaluating optimal recruitment and retention strategies, and assessing ED providers perceptions of facilitators and barriers to protocol use and protocol adherence.
The soon to be published NHBLI guidelines for managing SCD will be used as the standard protocol with the modification of basing the initial dose of pain medicine on patient weight. The standard protocol will recommend re-assessment, and re-dosing with possible dose escalation, every 20-30 minutes. Repeat doses for patients randomized to the weight-based protocol, when necessary, will be maintained or provided at 1 dose level increase (no more than 25%) above the initial dose. For patients randomized to the patient -specific protocol, the SCD provider has experience with the individual patient and is best qualified to make dosing and frequency recommendations based upon doses required during past ED and hospital visits for treatment of VOC, and on daily opioid use if applicable. There is no set maximum dose for patients randomized to the patient-specific protocols.
Both the patient-specific and standard protocols will be available in the ED via a patient's electronic medical record. Upon ED arrival, providers will retrieve the patient's study protocol (patient-specific, or standard) which will include the starting agents, and doses, the subsequent analgesic recommendations, and order medications according to the pre-determined protocol.
The study will be conducted at the emergency departments of the University of Cincinnati Medical Center and the Mt. Sinai Hospital in New York. Patients will be enrolled in the study for up to 12-months, but may contribute no more that five different ED visits for VOC pain control during enrollment to allow for a larger number of different patients.
Study outcomes will be compared between ED visits of patients randomized to a patient-specific vs. a standard SCD protocol. The primary outcome will be the difference in pain score from ED arrival to discharge, up to 6 hours, as measured using a visual analogue scale. The trajectories of average pain scores from immediately prior to administration of 1st analgesic dose to discharge by 30 minute increments for each treatment group will also be calculated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Specific dose of Morphine Sulfate or Hydromorphone | Experimental | Drug: Hydromorphone (Patient Specific dosing), Drug: Morphine Sulfate (Patient Specific dosing)A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 5 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history. |
| Standard dose of Morphine Sulfate or Hydromorphone | Active comparator | Drug: Hydromorphone (Standardized, weight-based dosing), Drug: Morphine Sulfate (Standardized, weight-based dosing)A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult SCD patients with genotypes SS, SC, SB+, or SB-
Key exclusion criteria (7 listed)
- Patients with sickle cell trait
- Allergic to both morphine sulfate and hydromorphone,
- Patients who have an explicit care plan that states they cannot be admitted to the hospital for pain control,
- Non-English speaking,
- Patients admitted for a medical complication,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydromorphone (Standardized, weight-based dosing)Also: DilaudidStandardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based). | Drug | Standard dose of Morphine Sulfate or Hydromorphone |
| Morphine Sulfate (Standardized, weight-based dosing)Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based). | Drug | Standard dose of Morphine Sulfate or Hydromorphone |
| Hydromorphone (Patient Specific dosing)Also: DilaudidPatient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team. | Drug | Patient Specific dose of Morphine Sulfate or Hydromorphone |
| Morphine Sulfate (Patient Specific dosing)Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team. | Drug | Patient Specific dose of Morphine Sulfate or Hydromorphone |
Primary outcome
Difference in Pain Score as Measured by a Visual Analogue Scale (VAS)
Time frame: Arrival in ED to discharge from the ED, up to 6 hours
Each ED study visit was the unit of analysis for the statistical methods addressing the primary outcome. The primary outcome was change in pain score from arrival to discharge. Pain severity was assessed at arrival and discharge from ED using a 100 mm visual analogue scale (VAS). The VAS range is 0 to 100 with 0 indicating "no pain" and 100 indicating "pain as bad as it could be" or "worst imaginable pain".Discharge was defined by which one of the following occurred first: (a) decision to admit to hospital; (b) patient physically leaves the ED to home; or (c) after six hours of observation in the ED. Thus, the difference in pain scores were calculated as the arrival minus discharge VAS scores, with higher positive pain difference or change scores indicating greater pain reduction.
11 secondary outcomes
Change in Pain Visual Analogue Scale (VAS) Scores Over Time
Time frame: Every 30 minutes from arrival in ED to discharge from the ED, up to 6 hours
Incidence of Nausea During Emergency Department Visits
Time frame: From placement in Emergency Department (ED) treatment room to discharge from the ED, up to 6 hours
Incidence of Vomiting During Emergency Department Visits
Time frame: From placement in ED treatment room to discharge from the ED, up to 6 hours
Incidence of a Decrease in Systolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit
Time frame: From placement in ED treatment room to discharge from the ED, up to 6 hours
Incidence of a Decrease in Diastolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit
Time frame: From placement in ED treatment room to discharge from the ED, up to 6 hours
Incidence of Oxygen Desaturation (< 95%) (YES) During Emergency Department Visit
Time frame: From placement in ED treatment room to discharge from the ED, up to 6 hours
Incidence of Respiratory Distress (YES) During Emergency Department Visit
Time frame: From placement in ED treatment room to discharge from the ED, up to 6 hours
Incidence of Sedation During Emergency Department Visit
Time frame: From placement in ED treatment room to discharge from the ED, up to 6 hours
Incidence of the Need for Supplemental Oxygen During Emergency Department Visit
Time frame: Following the initiation of opioid therapy until discharge from the ED, up to 6 hours
Incidence of the Administration of Naloxone During Emergency Department Visit
Time frame: Following the initiation of opioid therapy until discharge from the ED, up to 6 hours
Incidence of the Need for Assistive Ventilation
Time frame: Following the initiation of opioid therapy until discharge from the ED, up to 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Sickle Cell Disease
RecruitingObservational study
Blood Sampling for Research Related to Sickle Cell Disease
Sickle Cell Trait, Sickle Cell Disease
Active, not recruitingPhase 2/3
A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)
Sickle Cell Disease
Enrolling by invitationObservational study
Blood Collection for Research Related to Certain Diseases Involving Blood Vessels
Sickle Cell Disease
RecruitingPhase 1/2
Repeat Peripheral Blood Stem Cell Transplantation for Patients With Sickle Cell Disease and Falling Donor Myeloid Chimerism Levels
Myeloid Chimerism
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Tanabe, PhD principal investigator
Duke University School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone (Standardized, weight-based dosing), Morphine Sulfate (Standardized, weight-based dosing) and Hydromorphone (Patient Specific dosing) in people with Sickle Cell Disease, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Pain Score as Measured by a Visual Analogue Scale (VAS) (time frame: Arrival in ED to discharge from the ED, up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.