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Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures

NCT ID: NCT03564093

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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.

Detailed Description

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Conditions

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Pain Anesthesia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

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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

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Dexmedetomidine Placebo

Eligibility Criteria

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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

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Outi Peltoniemi

Adjunct Professor of Pediatric Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Outi Peltoniemi

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Outi Peltoniemi

Role: CONTACT

Phone: +35883155837

Email: [email protected]

Facility Contacts

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Outi Peltoniemi

Role: primary

Miikka Tervonen

Role: backup

Other Identifiers

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INDEXER

Identifier Type: -

Identifier Source: org_study_id