Sickle Cell DiseasePhase 2NCT00711698
Comparison of Patient Controlled Analgesia (PCA) Versus Bolus Narcotic Therapy for the Treatment of Vaso-Occlusive Crisis (VOC)
A Phase 2 study testing nurse-administered intermittent IV bolus opioid therapy (NAIBOD) in people with Sickle Cell Disease and Vaso-occlusive Crisis, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to find out the best way to give narcotics for pain relief in adults with sickle cell disease and painful crisis. This study is a comparison of two ways of giving narcotics. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sickle Cell Disease, Vaso-occlusive Crisis
- What is being tested?
- nurse-administered intermittent IV bolus opioid therapy (NAIBOD)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to 1 Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented sickle cell disease
- Signed consent in outpatient clinic or during a prior hospitalization
- 18+ years of age
- Seen in the ED with sickle cell pain crisis - this will be based on patients chief complaint that they are in a VOC.
- Requires IV administration of narcotics (has failed oral narcotic therapy at home)
- Must be 2 weeks since their last randomization on this study.
Who cannot join
- Contraindication to the use of IV narcotics
- Hypotension with systolic blood pressure (SBP) ≤ 90
- Respiratory rate ≤9
- Altered mental status
- Patient unable to understand how to use the PCA device
- Patient unwilling to use PCA device
Show all 10Show fewer
- Pulse oximeter reading of ≤ 94% on room air
- Patient is allergic to IV morphine \& hydromorphone \& fentanyl.
- Patient is allergic to oral hydromorphone \& morphine \& oxycodone
- Patient has been randomized on this study 3 times before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PCA for Pain Control in Adults With Sickle Cell Disease in the Emergency Department (ED) Decreases Admission Rates Over Standard Bolus Therapy
This research is being done to find out the best way to give narcotics for pain relief in adults with sickle cell disease and painful crisis. This study is a comparison of two ways of giving narcotics. The first way is what occurs now in the Emergency Acute Care Unit (EACU) where patients are given a single intravenous (iv) dose of a narcotic which is repeated by the nurse as needed to control the pain. The second way is to provide a single iv dose of narcotic and then allow the patient to push a button and receive one or more additional doses of narcotic when he/she thinks it is needed. Our hypothesis is that PCA will be a more effective way of controlling pain.
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Being tested
- Patient controlled analgesia, nurse-administered intermittent IV bolus opioid therapy (NAIBOD)
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient controlled analgesiaProcedure or surgery
Patients in this arm will be treated with a bolus of narcotic followed by PCA
nurse-administered intermittent IV bolus opioid therapy (NAIBOD)Drug
In this arm patients will receive the current standard of care of IV bolus narcotic therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | In this arm patients will be randomized to receive a bolus of narcotic followed by PCA. Receives: Procedure: Patient controlled analgesia |
| 2 | Active comparator | In this arm patients will be randomized to the current standard of care of bolus narcotic treatment. Receives: Drug: nurse-administered intermittent IV bolus opioid therapy (NAIBOD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in admissions for those treated with a PCA in the ED v those that are given bolus narcotic dosing
Measured: Measured at time of discharge from ED
Secondary outcomes (2)
Length of stay
Measured: Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made
Total narcotic used
Measured: Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2009 (estimated)
- Study completion1 Sep 2009 (estimated)
Why it stopped: technical difficulties coordinating study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Lanzkron, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711698
- Sponsor's protocol ID
- NA_00001163
- Status last verified
- Mar 2017
- First submitted
- 7 Jul 2008
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCA for Pain Control in Adults With Sickle Cell Disease in the Emergency Department (ED) Decreases Admission Rates Over Standard Bolus Therapy
- ClinicalTrials.gov ID
- NCT00711698
- Acronym / sponsor ID
- NA_00001163
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: technical difficulties coordinating study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (estimated)
- Study completion
- 1 Sep 2009 (estimated)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to find out the best way to give narcotics for pain relief in adults with sickle cell disease and painful crisis. This study is a comparison of two ways of giving narcotics. The first way is what occurs now in the Emergency Acute Care Unit (EACU) where patients are given a single intravenous (iv) dose of a narcotic which is repeated by the nurse as needed to control the pain. The second way is to provide a single iv dose of narcotic and then allow the patient to push a button and receive one or more additional doses of narcotic when he/she thinks it is needed. Our hypothesis is that PCA will be a more effective way of controlling pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Patient controlled analgesiaIn this arm patients will be randomized to receive a bolus of narcotic followed by PCA. |
| 2 | Active comparator | Drug: nurse-administered intermittent IV bolus opioid therapy (NAIBOD)In this arm patients will be randomized to the current standard of care of bolus narcotic treatment. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented sickle cell disease
- Signed consent in outpatient clinic or during a prior hospitalization
- 18+ years of age
- Seen in the ED with sickle cell pain crisis - this will be based on patients chief complaint that they are in a VOC.
- Requires IV administration of narcotics (has failed oral narcotic therapy at home)
Key exclusion criteria (10 listed)
- Contraindication to the use of IV narcotics
- Hypotension with systolic blood pressure (SBP) ≤ 90
- Respiratory rate ≤9
- Altered mental status
- Patient unable to understand how to use the PCA device
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 |
|---|---|---|
| Patient controlled analgesiaPatients in this arm will be treated with a bolus of narcotic followed by PCA | Procedure or surgery | 1 |
| nurse-administered intermittent IV bolus opioid therapy (NAIBOD)In this arm patients will receive the current standard of care of IV bolus narcotic therapy | Drug | 2 |
Primary outcome
Decrease in admissions for those treated with a PCA in the ED v those that are given bolus narcotic dosing
Time frame: Measured at time of discharge from ED
2 secondary outcomes
Length of stay
Time frame: Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made
Total narcotic used
Time frame: Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
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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.
Sophie Lanzkron, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nurse-administered intermittent IV bolus opioid therapy (NAIBOD) in people with Sickle Cell Disease and Vaso-occlusive Crisis, run by Johns Hopkins University at 1 site 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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Decrease in admissions for those treated with a PCA in the ED v those that are given bolus narcotic dosing (time frame: Measured at time of discharge from ED). 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 24 Mar 2017.