PruritisPhase 3NCT00323154
Nalbuphine for the Treatment of Opioid Induced Pruritus in Children
A Phase 3 study testing Nalbuphine in people with Pruritis, run by University of British Columbia at 1 site in Canada.
Trial summary
Itching is a frequent and disturbing side effect of the use of pain medication such as morphine. In the post-operative period, it can be more distressing to pediatric patients than their pain. The current first line treatment, an antihistamine (Benadryl), has a low efficacy. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Pruritis
- What is being tested?
- Nalbuphine
- How many people
- 134 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2004to Dec 2004
- Phase
- Phase 3
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Postoperative morphine administration
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia's Children's Hospital
Vancouver, British Columbia
About this study
Itching is a frequent and disturbing side effect of the use of pain medication such as morphine. In the post-operative period, it can be more distressing to pediatric patients than their pain. The current first line treatment, an antihistamine (Benadryl), has a low efficacy. This treatment causes sleepiness and may be dangerous when used in combination with other drugs.
Nalbuphine has analgesic properties similar to morphine as well as the ability to reverse some morphine-induced side effects, such as respiratory depression and itching. Nalbuphine has been used effectively for patients undergoing Caesarean sections. However, the effectiveness of nalbuphine in the pediatric population has not been investigated.
We want to determine the efficacy of nalbuphine in the treatment of itching after morphine for postoperative pain relief. We will use a novel method to measure the effect of the treatment using an intensity scale before and after the drug, to determine the intensity difference.
Read the detailed description
PURPOSE Primary To determine the efficacy of nalbuphine (50 - 100 mcg/kg intravenously) in the treatment of opioid induced pruritus in a multi-center tertiary care pediatric patient population.
Secondary Determine the effect of treatment with nalbuphine on a subjects analgesia and level of sedation.
HYPOTHESIS
Primary Outcome:
Nalbuphine will be effective in the treatment of opioid induced pruritus; a 50% reduction in pruritus intensity will be considered clinically significant.
Secondary Outcome:
Treatment with nalbuphine will not result in attenuation of analgesia or an increase in sedation
JUSTIFICATION Itch is a frequent and disturbing side effect of opioid use. A recent internal review of the pediatric pain service at the University of Alberta Hospital, Edmonton, Alberta found a 40% incidence of pruritus in patients receiving opioids. A similar review at British Columbia Children's Hospital demonstrated a 22% of patients incidence of pruritus.
OBJECTIVES The compare the efficacy of nalbuphine to placebo for the treatment of opioid-induced pruritus. It is anticipated that nalbuphine will result in a greater than 50% reduction in pruritus intensity.
RESEARCH METHOD This study will be a randomized, double-blinded, placebo controlled trial of nalbuphine for the treatment of opioid-induced pruritus. Pruritus intensity will be measured using a standardized assessment tool / Color Analog Scale (CAS). This is a metric scale which will be used to quantify pruritus on a scale of zero to ten. Using this scale a score of zero is represented by white, increasing pruritus severity being represented by darker shades of the color red, along a ruler.
Data analysis will be based on intenton to treat. It will be a multi-center study involving tertiary care centers with acute pediatric pain services.
Subjects will be divided into two groups by computer generated block randomization; one group will receive treatment with nalbuphine while the other will receive placebo. The patient and investigator will be blinded to the treatment administered.
REASON FOR PLACEBO CONTROLLED STUDY DESIGN Current first line therapy for opioid induced pruritus, with diphenhydramine is associated with a low efficacy (33%) (1). Recognizing that there can be up to 30% self report response to placebo, it is felt that conducting this study as a placebo-controlled trial will be necessary for the demonstration of significant improvement in pruritus intensity.
- Conditions
- Pruritis
- Being tested
- Nalbuphine
- Keywords
- Morphine, analgesia
- Medical subject headings
- Pruritus, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritis intensity
Secondary outcomes (1)
Pain, sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startMar 2004
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Carolyne Montgomery, MD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323154
- Sponsor's protocol ID
- C02-0589
- Other IDs
- W02-0175
- Status last verified
- Sep 2008
- First submitted
- 8 May 2006
- Last updated
- 25 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nalbuphine for the Treatment of Opioid Induced Pruritus in Children
- ClinicalTrials.gov ID
- NCT00323154
- Acronym / sponsor ID
- C02-0589
- Conditions
- Pruritis
- Keywords
- Morphine, analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 9 May 2006 (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.
Itching is a frequent and disturbing side effect of the use of pain medication such as morphine. In the post-operative period, it can be more distressing to pediatric patients than their pain. The current first line treatment, an antihistamine (Benadryl), has a low efficacy. This treatment causes sleepiness and may be dangerous when used in combination with other drugs.
Nalbuphine has analgesic properties similar to morphine as well as the ability to reverse some morphine-induced side effects, such as respiratory depression and itching. Nalbuphine has been used effectively for patients undergoing Caesarean sections. However, the effectiveness of nalbuphine in the pediatric population has not been investigated.
We want to determine the efficacy of nalbuphine in the treatment of itching after morphine for postoperative pain relief. We will use a novel method to measure the effect of the treatment using an intensity scale before and after the drug, to determine the intensity difference.
Detailed description
PURPOSE Primary To determine the efficacy of nalbuphine (50 - 100 mcg/kg intravenously) in the treatment of opioid induced pruritus in a multi-center tertiary care pediatric patient population.
Secondary Determine the effect of treatment with nalbuphine on a subjects analgesia and level of sedation.
HYPOTHESIS
Primary Outcome:
Nalbuphine will be effective in the treatment of opioid induced pruritus; a 50% reduction in pruritus intensity will be considered clinically significant.
Secondary Outcome:
Treatment with nalbuphine will not result in attenuation of analgesia or an increase in sedation
JUSTIFICATION Itch is a frequent and disturbing side effect of opioid use. A recent internal review of the pediatric pain service at the University of Alberta Hospital, Edmonton, Alberta found a 40% incidence of pruritus in patients receiving opioids. A similar review at British Columbia Children's Hospital demonstrated a 22% of patients incidence of pruritus.
OBJECTIVES The compare the efficacy of nalbuphine to placebo for the treatment of opioid-induced pruritus. It is anticipated that nalbuphine will result in a greater than 50% reduction in pruritus intensity.
RESEARCH METHOD This study will be a randomized, double-blinded, placebo controlled trial of nalbuphine for the treatment of opioid-induced pruritus. Pruritus intensity will be measured using a standardized assessment tool / Color Analog Scale (CAS). This is a metric scale which will be used to quantify pruritus on a scale of zero to ten. Using this scale a score of zero is represented by white, increasing pruritus severity being represented by darker shades of the color red, along a ruler.
Data analysis will be based on intenton to treat. It will be a multi-center study involving tertiary care centers with acute pediatric pain services.
Subjects will be divided into two groups by computer generated block randomization; one group will receive treatment with nalbuphine while the other will receive placebo. The patient and investigator will be blinded to the treatment administered.
REASON FOR PLACEBO CONTROLLED STUDY DESIGN Current first line therapy for opioid induced pruritus, with diphenhydramine is associated with a low efficacy (33%) (1). Recognizing that there can be up to 30% self report response to placebo, it is felt that conducting this study as a placebo-controlled trial will be necessary for the demonstration of significant improvement in pruritus intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Postoperative morphine administration
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Nalbuphine | Drug | – |
Primary outcome
Pruritis intensity
1 secondary outcome
Pain, sedation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2008.
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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.
Carolyne Montgomery, MD principal investigator
The University of British Columbia
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 Nalbuphine in people with Pruritis, run by University of British Columbia at 1 site in Canada.
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 0 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 25 Sep 2008. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pruritis intensity. 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 25 Sep 2008.