Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

NCT01951963 | Completed Phase 4 Results

• 1 other identifier: A12-158
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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

Keywords

pain management; ketamine; morphine; pediatrics; emergency medicine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pain Scale Rating Agreement Among Patient, Parent, and Research Staff

  Up to 3 hours post pain medication administration

Study Arms (2)

Ketamine

EXPERIMENTAL

Ketamine, single dose, 0.3 mg/kg, IV

Drug: Ketamine

Morphine

ACTIVE COMPARATOR

Morphine, single dose, 0.05 mg/kg, IV

Drug: Morphine

Interventions

Ketamine DRUG

Ketamine

Morphine DRUG

Morphine

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Ketamine; Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Aaron Burnett
• Organization: Health Partners

Aaron.M.Burnett@HealthPartners.Com

651-254-5304

Study Officials

• Aaron M Burnett, MD

  Regions Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 27, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 3, 2018
• Results First Posted: October 16, 2017

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)