Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
Information provided by (Responsible Party):
HealthPartners Institute

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

Layout table for study information
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

Resource links provided by the National Library of Medicine


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



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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951963


Locations
Layout table for location information
United States, Minnesota
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Sponsors and Collaborators
HealthPartners Institute
Investigators
Layout table for investigator information
Principal Investigator: Aaron M Burnett, MD Regions Hospital

Layout table for additonal information
Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT01951963     History of Changes
Other Study ID Numbers: A12-158
First Posted: September 27, 2013    Key Record Dates
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:
Layout table for MeSH terms
Morphine
Ketamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action