Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures (INDEXER)

  • STATUS
    Recruiting
  • End date
    Jun 10, 2023
  • participants needed
    112
  • sponsor
    University of Oulu
Updated on 4 March 2022
analgesia
dexmedetomidine
sedative
pain relieving

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 1g/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.

Details
Condition Pain, Anesthesia
Treatment Intranasal Drug
Clinical Study IdentifierNCT03564093
SponsorUniversity of Oulu
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

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
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