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Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures

NCT03564093 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2023-12-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Outi Peltoniemi · Oulu University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2025-03-14
Completion
2025-06-10

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03564093 on ClinicalTrials.gov