CompletedPhase 3ketamine

Pain Reduction With Intranasal Medications for Extremity Injuries

Sponsored by Children's Hospital Medical Center, Cincinnati

NCT ID
NCT02778880
Target Enrollment
90 participants
Start Date
2016-03-31
Est. Completion
2017-03-21

About This Study

This study compares the analgesic effect of intranasal sub-dissociative dosing of ketamine and intranasal fentanyl in children presenting to the Emergency Department with acute extremity injuries.

Conditions Studied

PainTraumatic Limb Injury

Interventions

  • Ketamine
  • Fentanyl

Eligibility

Age:8 Years - 17 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* 8 years to 17 years (up to the 18th birthday)
* Presenting to emergency department with one or more extremity injuries
* Visual analog scale score 35 mm or greater
* Parent or legal guardian present and willing to provide written consent

Exclusion Criteria:

* Received narcotic pain medication prior to arrival
* Evidence of significant head, chest, abdomen, or spine injury
* Glasgow coma score less than 15 or unable to self report pain score
* Nasal trauma or aberrant nasal/airway anatomy
* Active epistaxis
* Allergy to ketamine, fentanyl or meperidine
* Non-English speaking parent and/or child
* History of psychosis
* Postmenarchal female without a urine or serum assay documenting the absence of pregnancy
* Brought in my juvenile detention center or in police custody
* Pregnancy

Study Locations (1)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 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