IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures

Brief Summary

The primary objective of this study is to evaluate the sedative, and analgesic effects of intranasal (IN) Dexmedetomidine (DEX) in children presenting to a Pediatric Emergency Department (PED) who undergo conscious sedation for reduction of closed distal forearm fractures when compared to those receiving intravenous (IV) Ketamine. The secondary objective is to compare each sedation technique for safety and procedural outcomes.

Intervention / Treatment

  • Drug: Dexmedetomidine
  • Drug: Ketamine

Condition or Disease

  • Conscious Sedation
  • Distal Radius Fracture

Phase

Study Design

Study type: Interventional
Status: Unknown status
Study results: No Results Available
Age: 2 Years to 18 Years   (Child, Adult)
Enrollment: 40 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: May 01, 2018
Primary Completion: Apr 01, 2019
Completion Date: May 01, 2019
Study First Posted: Mar 15, 2018
Results First Posted: Aug 31, 2020
Last Updated: Mar 15, 2018

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Distal Forearm fractures are often are displaced requiring conscious sedation for closed reduction in the Emergency Department. Our institution's current standard of care consists of IN Fentanyl for baseline control of pain, and for those fractures requiring reduction; typically IV Ketamine is utilized. Ketamine is typically well tolerated but is not without concerns including hypertension, vomiting, and the rare but serious complication of laryngospasm. Dexmedetomidine (DEX) offers a possible alternative to IV Ketamine. DEX has been used safely in the critical care setting for both pediatrics and adults. It has been well documented as being quite effective in sedation, amnesia and analgesia. Using IN DEX for PED procedural sedation has the potential to obviate the need for IV placement and may offer a better conscious sedation profile than Ketamine with respect to sedation, analgesia, and adverse outcomes.

Our overall project would be to assess the efficiency of IN DEX in comparison to IV Ketamine, for proper sedation and analgesic coverage for children undergoing closed reduction of distal forearm fractures.

Eligibility Criteria

Sex: All
Minimum Age: 2
Maximum Age: 18

More Details

NCT Number: NCT03466242
Other IDs: 17-193
Study URL: https://ClinicalTrials.gov/show/NCT03466242
Last updated: Jun 17, 2022