NCT03564093

Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures

Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures: Randomized Double-blinded Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room. Patients of the pediatric emergency room at Oulu university hospital with any medical condition requiring a small painful procedure like i.v. cannulation or lumbar puncture are asked to join the investigator's study if they would seem to benefit from a sedative drug during the procedure. Patients are randomly assigned to treatment group receiving intranasal dexmedetomidine 1µg/kg and to placebo group receiving 4,5% saline solution. The primary outcome is the success of the procedure. Cardiovascular and respiratory effects, the pain experienced by the patient, sedation scores and duration of crying are also monitored.

Conditions

• Pain
• Anesthesia

Interventions

Type	Name	Description
DRUG	Intranasal Drug	1µg/kg of dexmedetomidine is given 30 minutes prior to intravenous cannulation or lumbar puncture
DRUG	Intranasal Drug	Intranasal 4,5% saline is given as a placebo 30 minutes prior to intravenous cannulation or lumbar puncture

Timeline

• Start date: 2018-03-15
• Primary completion: 2025-03-14
• Completion: 2025-06-10
• First posted: 2018-06-20
• Last updated: 2023-12-20

Locations

1 site across 1 country: Finland