Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

• ClinicalTrials.gov Identifier: NCT01951963
• Recruitment Status: Completed
• First Posted: September 27, 2013
• Results First Posted: October 16, 2017
• Last Update Posted: July 3, 2018
• Sponsor: HealthPartners Institute
• Information provided by (Responsible Party): HealthPartners Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Ketamine; Drug: Morphine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
• Study Start Date: December 2012
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Cumulative Narcotic Consumption [ Time Frame: 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.
2. Adverse Drug Reaction [ Time Frame: 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.

Other Outcome Measures:

1. Pain Scale Rating Agreement Among Patient, Parent, and Research Staff [ Time Frame: Up to 3 hours post pain medication administration ]

   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Minnesota

Regions Hospital

Saint Paul, Minnesota, United States, 55101

Sponsors and Collaborators

HealthPartners Institute

Investigators

• Principal Investigator: Aaron M Burnett, MD; Regions Hospital

More Information

• Responsible Party: HealthPartners Institute
• ClinicalTrials.gov Identifier: NCT01951963
• Other Study ID Numbers: A12-158
• First Posted: September 27, 2013
• Results First Posted: October 16, 2017
• Last Update Posted: July 3, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: We do not have a plan to share IPD

Keywords provided by HealthPartners Institute:

pain management; ketamine; morphine; pediatrics; emergency medicine

Additional relevant MeSH terms:

Ketamine; Morphine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics