Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures

NCT03564093 | Unknown Phase 4

• 1 other identifier: INDEXER
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Keywords

pediatrics; sedation; emergency room sedation; intranasal sedation; dexmedetomidine; intranasal dexmedetomidine; children; pediatric; pediatric sedation

Outcome Measures

Primary Outcomes (1)

• Success of the procedure

  The success of the first attempt of the procedure (venous cannulation or lumbar puncture) is evaluated at the end of the first attempt of the procedure. Succesfulness of venous cannulation is tested by the doctor on call by flushing the cannula with saline. If the cannula works without complications the cannulation is successfull. Lumbar puncture is successfull if all the samples needed from the liquor are collected.

  After the first attempt of the procedure. The procedure is attempted 30 minutes after the study drug administration.

Secondary Outcomes (12)

• The duration of the procedure

  The time from the start of the first attempt of the procedure to the success of the procedure. The procedure is attempted 30 after the study drug administration. Time from the first needle puncture to ending the procedure is recorded.

• Parents assessment of the patients pain during the procedure

  Parents return a questionnaire within 2 hours after the study drug has been administered.

• Patient pain VAS

  The numerical value of VAS is asked in the end of the follow up period of 2 hours.

• Patient pain FLACC

  Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.

• Patient sedation level

  Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

1µg/kg intranasal dexmedetomidine

Drug: Intranasal Drug

Placebo

PLACEBO COMPARATOR

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

Drug: Intranasal Drug

Interventions

Intranasal Drug DRUG

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

Also known as: Dexmedetomidine

Dexmedetomidine

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University Hospital

Oulu, Finland

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Administration, Intranasal; Dexmedetomidine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, Mucosal; Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Outi Peltoniemi

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Outi Peltoniemi

CONTACT

+35883155837; outi.peltoniemi@ppshp.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor of Pediatric Intensive Care

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: June 20, 2018
• Study Start: March 15, 2018
• Primary Completion: March 14, 2025
• Study Completion: June 10, 2025
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)