A Phase 2 interventional study of naloxone in Pain, Nausea and Pruritus, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-07-19.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
This is an investigator initiated dose finding study designed to determine the optimal dose of naloxone to prevent or minimize the most common side effects induced by opioids, namely itching, nausea, and vomiting. Male and female inpatients of the Children's Center of the Johns Hopkins Hospital, who are greater than 6 and less than 18 years of age with acute, moderate to severe pain, and who are to be treated with intravenous Patient controlled analgesia (IVPCA) morphine will be eligible for inclusion in this study. Patients will be recruited by a study investigator prior to the initiation of IVPCA therapy. The majority of patients will be post operative patients, and will start therapy and the investigational drug in the Post Anesthesia Care Unit or the Pediatric Intensive Care Unit. The investigators plan on studying between 10 and 99, male and female patients over a 2 year period.
In patients of all ages, opioids are the cornerstone of management of moderate to severe pain. Regardless of method of administration, all opioids produce unwanted side effects, including pruritus, nausea and vomiting, constipation, urinary retention, cognitive impairment, tolerance, dependence, and (rarely) respiratory depression. Based on the results of a previously completed randomized controlled trial, children and adolescents with moderate to severe pain, are now routinely treated in the Children's Center of the Johns Hopkins Hospital with a low dose naloxone infusion (0.25 mcg/kg/HOUR) whenever morphine intravenous patient controlled analgesia (IVPCA) or parent/nurse controlled analgesia (IVPNCA) is initiated. Although the previous study showed a marked reduction in the incidence and severity of pruritus and nausea, approximately a third of the patients still experience these side effects. The primary purpose of this study is to reduce this failure rate by determining if there is an optimal dose of naloxone to prevent opioid induced side effects as determined by a dose finding classic up down dose escalation method. The second aim is to determine the pharmacokinetics of morphine and naloxone and their metabolites at each of the naloxone infusion rates attempted. The investigators will measure morphine, naloxone, and their metabolites using a liquid chromatographic-electrospray ionization-tandem mass spectrometric method (LC/MS/MS). The final aim is to determine the pharmacogenetics of responders and non-responders using DNA isolated from patient blood. To accomplish this the investigators will need a single blood collection from patients currently being treated with IVPCA morphine and low dose intravenous naloxone.
354 studies on the registry are indexed under Pruritus; 74 are open to participants now.
This study's enrollment of 75 is above the median of 60 across 294 interventional studies indexed under Pruritus.
Browse Pruritus studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
continuous infusion of naloxone administered in escalating dosing from 0.05 mcg/kg/hr to 1.65 mcg/kg/hour
Drug: naloxone
continuous infusion of naloxone administered in escalating dosing from 0.05 mcg/kg/hr to 1.65 mcg/kg/hour
Number of Participants With Naloxone Side Effects
incidence of nausea, vomiting, pruritus following naloxone infusion
Time frame: 0-48 hours after infusion begins
75 participants were consented, but only 64 participants participated in this study and were placed in the experimental arm.
| Milestone | Naloxone |
|---|---|
| Started | 64 |
| Completed | 59 |
| Not completed | 5 |
| Withdrew: Lost to follow-up | 5 |
incidence of nausea, vomiting, pruritus following naloxone infusion
| participants | Naloxone |
|---|---|
| Number of Participants With Naloxone Side Effects | 32 (10 to 60) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | — | 0/59 (0%) | 32/59 (54.2%) |
| Event | Group 1 |
|---|---|
| Nausea, Vomiting or pruritisGastrointestinal disorders | 32/59 |
| Age, Categorical(Participants) | Group 1 |
|---|---|
| <=18 years | 64 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Group 1 |
|---|---|
| Mean | 12 ± 6 |
| Sex: Female, Male(Participants) | Group 1 |
|---|---|
| Female | 32 |
| Male | 32 |
| Region of Enrollment(Participants) | Group 1 |
|---|---|
| United States | 64 |
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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