Phase 2
N=64
Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents
Pain · Nausea · Pruritus
Bottom Line
View on ClinicalTrials.gov: NCT00330343 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Number of Participants With Naloxone Side Effects — 32 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- naloxone (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Naloxone Side Effects |
32 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Male and female patients greater than 6 and less than 18 years of age with acute, moderate to severe pain who are to start treatment with IVPCA morphine as inpatients of the Children's Center of the Johns Hopkins Hospital
Exclusion Criteria
- patients who require concomitant benzodiazepine administration
- allergic to opioids
- have been in an investigational drug trial within 1 month
- received opioids with in 7 days of the study
- parent with psychiatric illness which impairs their ability to provide consent parent who does not speak English
Data sourced from ClinicalTrials.gov (NCT00330343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.