Trials / Completed
CompletedNCT01951963
Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- HealthPartners Institute · Academic / Other
- Sex
- All
- Age
- 3 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ketamine | |
| DRUG | Morphine |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2013-09-27
- Last updated
- 2018-07-03
- Results posted
- 2017-10-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01951963. Inclusion in this directory is not an endorsement.