Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Ketamine; Drug: Morphine

• Registration Number: NCT01951963
• Lead Sponsor: HealthPartners Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-27
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2017-02-16
• Results First Submitted QC: 2017-09-14
• Results First Posted: 2017-10-16
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	Ketamine, single dose, 0.3 mg/kg, IV
Morphine	Morphine	Morphine, single dose, 0.05 mg/kg, IV

Primary Outcome Measures

Name	Time	Method
Adverse Drug Reaction	3 hours post study drug administration	Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED. the research team will complete the Adverse Event case report form to determine any adverse events occurring during the study period. Family members will be contacted via telephone 24 hours (±8 hours) following their visit in the Emergency Department to complete the Discharge Adverse Event case report form.
Cumulative Narcotic Consumption	3 hours post study drug administration	All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results.

Trial Locations

Locations (1)

Regions Hospital; 🇺🇸 Saint Paul, Minnesota, United States