Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

Phase 4CompletedNCT01951963

HealthPartners Institute77 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain

Interventions

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cumulative Narcotic Consumption

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.

Time frame: 3 hours post study drug administration

Adverse Drug Reaction

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.