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

University of Oulu

Status and phase: Enrolling; Phase 4

Conditions: Pain; Anesthesia

Treatments: Drug: Intranasal Drug

Study type: Interventional

Funder types: Other

Identifiers

NCT03564093

INDEXER

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Experimental group

Description:

1µg/kg intranasal dexmedetomidine

Treatment:

Drug: Intranasal Drug

Drug: Intranasal Drug

Placebo

Placebo Comparator group

Description:

0,01ml/kg intranasal 4,5% saline

Treatment:

Drug: Intranasal Drug

Drug: Intranasal Drug