Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures

• Status: Recruiting
• Trial end date: 2023-06-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oulu
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• Pediatric patients aged 1-12 years at the Oulu University Hospital emergency room who would benefit from sedative medication during small painful procedures like i.v. cannulation or lumbar puncture are asked to take part in our study

Exclusion Criteria:

• Allergy to dexmedetomidine or any supplementary elements of the Dexdor®-solution

• II or III degree AV-blockage without pacemaker

• Uncontrollable hypotension

• Stroke

• Critically ill patients who are admitted to the PICU

• Patients with clear cardiac or respiratory dysfunction

• Lowered level of consciousness

• Patients with increased risk of apnoeic events due to neurologic or metabolic conditions or extreme obesity

• A single patient can only take part in this study once.