CompletedPhase 4ketamine

Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

Sponsored by HealthPartners Institute

NCT ID
NCT01951963
Target Enrollment
77 participants
Start Date
2012-12
Est. Completion
2015-06

About This Study

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 Studied

Pain

Interventions

  • Ketamine
  • Morphine

Eligibility

Age:3 Years - 17 Years
Healthy Volunteers:No
View full eligibility 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

Study Locations (1)

Regions Hospital
Saint Paul, Minnesota, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source