Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
Completed · Phase 4
Conditions studied: Pain
In brief
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.
Key facts
- Study ID
- NCT01951963
- Run by
- HealthPartners Institute
- People needed
- 77
- Starts
- 2012-12-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2018-07-03
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Regions Hospital — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.