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OpenTrials
Completed

NCT Number: NCT01951963

Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

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.

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Key information

Conditions

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

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Morphine

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 27, 2013
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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