Phase 4
N=63
Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01951963 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Cumulative Narcotic Consumption — 19; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketamine (Drug); Morphine (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- HealthPartners Institute
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Narcotic Consumption |
19; 14 | — |
| PRIMARY Adverse Drug Reaction |
2; 3 | — |
Summary
The proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric patients requiring intravenous analgesia in an urban emergency department (ED) compared to a group of patients who receive morphine alone for pain management. Patients are randomized to receive either a single bolus of ketamine (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be accomplished using morphine. Patient, family member, and research staff pain scores will be recorded, until 3 hours post study medication administration. Family members are contacted via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be calculated for up to 3 hours post study medication administration and compared between the ketamine and morphine groups.
Eligibility Criteria
Inclusion Criteria
- Age: 3-17 years old
- Condition (medical or trauma) requiring opioid pain management per standard of care
- Need to establish an IV per standard of care
- Treating physician agrees to manage the patient's pain with morphine following randomization.
Exclusion Criteria
- Trauma Team Activation
- Known allergy to ketamine
- Family member unable/unavailable to provide informed consent
- When appropriate, patient unwilling to provide assent
- High suspicion of injury related to child abuse
- Patient and/or family member is non-English speaking
- Patient is incarcerated
Data sourced from ClinicalTrials.gov (NCT01951963). 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.