CompletedPhase 2ketamine

IN Sub-Dissociative Ketamine vs IN Fentanyl

Sponsored by Wake Forest University Health Sciences

NCT ID
NCT02521415
Target Enrollment
87 participants
Start Date
2015-12
Est. Completion
2016-11

About This Study

This single center, randomized control, double blind trial will prospectively examine the feasibility of intranasal, sub-dissociative (IN) ketamine versus intranasal fentanyl for pain control in the pediatric emergency department setting. The investigators hypothesize that IN ketamine may provide a safe and effective alternative to IN fentanyl for children with suspected, isolated extremity fractures. Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.

Conditions Studied

Bone Fracture

Interventions

  • ketamine
  • fentanyl
  • ibuprofen or acetaminophen

Eligibility

Age:4 Years - 17 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* single suspected, isolated extremity fracture that requires analgesia

Exclusion Criteria:

* GCS \< 15 at ED presentation,
* reported allergy or adverse reaction to ketamine or fentanyl,
* pregnancy,
* intoxication,
* hypotension (less than 70 mmHg +2x age or less than 90 mm Hg for patients greater than 11 years of age)
* weight \> 70 kg
* patients receiving opioid analgesia administered prior to arrival
* multiply injured patients (injuries to multiple extremities)
* aberrant nasal anatomy that precludes IN medications

Study Locations (1)

Carolinas Medical Center Main - Levine Children's Hospital Emergency Department
Charlotte, North Carolina, 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