PainPhase 3COMPARENCT01380197
Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally
A Phase 3 study testing Morphine and Nubain in people with Pain and Sickle Cell Disease, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). Read more about this study
- Who is it for?
- Ages 6 to 19 years
- Conditions the study is for
- Pain, Sickle Cell Disease
- What is being tested?
- Morphine and Nubain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2010to 18 Oct 2016
- Phase
- Phase 3
- 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 6 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with sickle cell disease (SS, SC, SβThal) who are hospitalized for acute painful episodes
- 6 years old and < 19 years old
- Normal baseline chest radiograph
- Normal renal and hepatic function within the previous 12 months
Who cannot join
- Previous patient participation in this clinical trial
- Any patient on chronic transfusion Any patient with pulmonary infiltrate on chest radiograph on admission
- Any patient with DSM diagnosis, excluding those with Attention Deficit Disorder, on or off treatment
- Any patient with documented allergy to either study drug
- Any patient with known evidence of an underlying disease that would interfere with evaluation of a therapeutic response such as:
- Hepatic dysfunction (3x ALT),
Show all 13Show fewer
- Renal dysfunction (Cr > 1 children/adolescents, Cr >2 adults),
- Pulmonary Hypertension (TRJ >3.0),
- Cardiac dysfunction.
- Any patient with symptoms of an acute stroke.
- Any patient known or suspected to be pregnant.
- Any patient with priapism
- The patient or guardian who will not give consent or assent to be randomized.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30303
About this study
Official title: Choosing Opioid Management for Pain and Analyzing ACS Rates Equally
The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. Painful episodes are the most common cause of hospitalization, morbidity, and impairment for SCD patients. There is no therapy that completely prevents or directly aborts painful events for all patients. Consequently, treatment for acute VOC is primarily supportive using hydration and medicinal pain control. Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects.
The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. The investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.
- Conditions
- Pain, Sickle Cell Disease
- Being tested
- Morphine, Nubain
- Keywords
- pain, sickle cell, nubain, morphine, acute chest, side effects
- Medical subject headings
- Pain, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).
NubainDrug
Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).
| Study group | Role | What they receive |
|---|---|---|
| Randomizing particiipants to Morphine | Active comparator | Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis Receives: Drug: Morphine |
| Randomization to Nubain | Active comparator | Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients Receives: Drug: Nubain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Chest Syndrome
Number of Participants with Acute Chest Syndrome or A new pulmonry infiltrate on Chest X-ray
Measured: 3 days
Secondary outcomes (1)
Number of Participants Who Experienced Pain Relief
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study start26 May 2010
- Primary completion14 Jan 2014
- Study completion18 Oct 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 PainStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Collaborators
- Atlanta Clinical and Translational Science Institute
- Responsible party
- Principal investigator, Saadia Khizer, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380197
- Sponsor's protocol ID
- 09-076
- Acronym
- COMPARE
- Status last verified
- Jan 2018
- First submitted
- 22 Jun 2011
- Last updated
- 20 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choosing Opioid Management for Pain and Analyzing ACS Rates Equally
- ClinicalTrials.gov ID
- NCT01380197
- Acronym / sponsor ID
- COMPARE / 09-076
- Conditions
- Pain, Sickle Cell Disease
- Keywords
- pain, sickle cell, nubain, morphine, acute chest, side effects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Collaborators
- Atlanta Clinical and Translational Science Institute
- Study start
- 26 May 2010 (actual)
- Primary completion
- 14 Jan 2014 (actual)
- Study completion
- 18 Oct 2016 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 16 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. Painful episodes are the most common cause of hospitalization, morbidity, and impairment for SCD patients. There is no therapy that completely prevents or directly aborts painful events for all patients. Consequently, treatment for acute VOC is primarily supportive using hydration and medicinal pain control. Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects.
The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. The investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomizing particiipants to Morphine | Active comparator | Drug: MorphineRandomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis |
| Randomization to Nubain | Active comparator | Drug: NubainRandomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients |
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with sickle cell disease (SS, SC, SβThal) who are hospitalized for acute painful episodes
- 6 years old and < 19 years old
- Normal baseline chest radiograph
- Normal renal and hepatic function within the previous 12 months
Key exclusion criteria (13 listed)
- Previous patient participation in this clinical trial
- Any patient on chronic transfusion Any patient with pulmonary infiltrate on chest radiograph on admission
- Any patient with DSM diagnosis, excluding those with Attention Deficit Disorder, on or off treatment
- Any patient with documented allergy to either study drug
- Any patient with known evidence of an underlying disease that would interfere with evaluation of a therapeutic response such as:
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 |
|---|---|---|
| MorphineLoading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled. Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs). | Drug | Randomizing particiipants to Morphine |
| NubainLoading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled. Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs). | Drug | Randomization to Nubain |
Primary outcome
Acute Chest Syndrome
Time frame: 3 days
Number of Participants with Acute Chest Syndrome or A new pulmonry infiltrate on Chest X-ray
1 secondary outcome
Number of Participants Who Experienced Pain Relief
Time frame: 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Morphine and Nubain in people with Pain and Sickle Cell Disease, run by Children's Healthcare of Atlanta 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 4 inclusion and 13 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 20 Feb 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Feb 2015). 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?
Acute Chest Syndrome (time frame: 3 days). 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 20 Feb 2018.