Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

NCT ID: NCT01951963

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-06-30

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ketamine

Ketamine, single dose, 0.3 mg/kg, IV

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Morphine

Morphine, single dose, 0.05 mg/kg, IV

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

Interventions

Ketamine

Intervention Type: DRUG

Morphine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron M Burnett, MD

Role: PRINCIPAL_INVESTIGATOR

Regions Hospital

Locations

Regions Hospital

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

A12-158

Identifier Type: -

Identifier Source: org_study_id