Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures

NCT ID: NCT03564093

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2025-06-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dexmedetomidine

1µg/kg intranasal dexmedetomidine

Group Type: EXPERIMENTAL

Intranasal Drug

Intervention Type: DRUG

1µg/kg of dexmedetomidine is given 30 minutes prior to intravenous cannulation or lumbar puncture

Placebo

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

Group Type: PLACEBO_COMPARATOR

Intranasal Drug

Intervention Type: DRUG

Intranasal 4,5% saline is given as a placebo 30 minutes prior to intravenous cannulation or lumbar puncture

Interventions

Intranasal Drug

1µg/kg of dexmedetomidine is given 30 minutes prior to intravenous cannulation or lumbar puncture

Intervention Type: DRUG

Intranasal Drug

Intranasal 4,5% saline is given as a placebo 30 minutes prior to intravenous cannulation or lumbar puncture

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine; Placebo

Eligibility 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oulu

OTHER

Sponsor Role: lead

Responsible Party

Outi Peltoniemi

Adjunct Professor of Pediatric Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Outi Peltoniemi

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Locations

Oulu University Hospital

Oulu, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Outi Peltoniemi

Role: CONTACT

outi.peltoniemi@ppshp.fi

+35883155837

Facility Contacts

Outi Peltoniemi

Role: primary

outi.peltoniemi@ppshp.fi

+35883155837

Miikka Tervonen

Role: backup

miikka.tervonen@ppshp.fi

+35883158428

Other Identifiers

INDEXER

Identifier Type: -

Identifier Source: org_study_id