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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

Tracking Information
First Submitted Date  ICMJE September 24, 2013
First Posted Date  ICMJE September 27, 2013
Results First Submitted Date  ICMJE February 16, 2017
Results First Posted Date  ICMJE October 16, 2017
Last Update Posted Date July 3, 2018
Study Start Date  ICMJE December 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
  • Cumulative narcotic consumption [ Time Frame: 3 hours post study drug administration ]
  • Adverse drug reaction [ Time Frame: 3 hours post study drug administration ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
Change in self-assessed pain rating [ Time Frame: 3 hours post study medication administration ]
Current Other Pre-specified Outcome Measures
 (submitted: September 14, 2017)
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.
Original Other Pre-specified Outcome Measures
 (submitted: September 24, 2013)
Pain scale rating agreement among patient, parent, and research staff [ Time Frame: 15 minute increments for 3 hours post pain medication administration ]
 
Descriptive Information
Brief Title  ICMJE Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
Official Title  ICMJE Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Ketamine
  • Drug: Morphine
Study Arms  ICMJE
  • Experimental: Ketamine
    Ketamine, single dose, 0.3 mg/kg, IV
    Intervention: Drug: Ketamine
  • Active Comparator: Morphine
    Morphine, single dose, 0.05 mg/kg, IV
    Intervention: Drug: Morphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2016)
77
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2013)
300
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01951963
Other Study ID Numbers  ICMJE A12-158
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We do not have a plan to share IPD
Responsible Party HealthPartners Institute
Study Sponsor  ICMJE HealthPartners Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aaron M Burnett, MD Regions Hospital
PRS Account HealthPartners Institute
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP