Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

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 Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Morphine; Drug: Ketamine

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketamine; Ketamine, single dose, 0.3 mg/kg, IV	Drug: Ketamine
Active Comparator: Morphine; Morphine, single dose, 0.05 mg/kg, IV	Drug: Morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 hours post study drug administration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scale Rating Agreement Among Patient, Parent, and Research Staff	FLACC scores were assessed on the patient using the FLACC scale (0-10) by the parent, treating RN/trained research assistant.; FLACC - Parents 30 Minutes Post dose; FLACC - Staff 30 Minutes Post dose Wong-Baker Faces scale is a self-assessment of pain Scale of 1-10 pain.	Up to 3 hours post pain medication administration

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Investigators: Principal Investigator: Aaron M Burnett, MD, Regions Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 27, 2013

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: June 5, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: pediatrics; morphine; ketamine; pain management; emergency medicine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Ketamine; Morphine
• Other Study ID Numbers: A12-158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We do not have a plan to share IPD