CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 77 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01951963
NCT01951963Phase 4Completed

Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

HealthPartners Institute·interventional·Posted Sep 27, 2013·Updated Jul 3, 2018

In Brief

A Phase 4 clinical trial evaluating Ketamine and Morphine for Pain. Completed, enrolled 77 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 27, 2013
Enrollment StartDec 1, 2012
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.8 years ago

Interventions

Ketaminedrug

Morphinedrug