Clinical Trials Directory

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

TypeNameDescription
DRUGKetamine
DRUGMorphine

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.