Using intranasal dexmedetomidine for sedation in children during emergency room procedures
Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures: Randomized Double-blinded Clinical Trial
PHASE4 · University of Oulu · NCT03564093
This study is testing if a nose spray called dexmedetomidine can safely help children aged 1-12 feel calm during small painful procedures in the emergency room.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 1 Year to 12 Years |
| Sex | All |
| Sponsor | University of Oulu (other) |
| Locations | 1 site (Oulu) |
| Trial ID | NCT03564093 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of intranasal dexmedetomidine as a sedative for pediatric patients undergoing small painful procedures in the emergency room. Children aged 1-12 years at Oulu University Hospital who require sedation for procedures like intravenous cannulation or lumbar puncture will be randomly assigned to receive either dexmedetomidine or a placebo saline solution. The primary outcome will be the success of the procedure, while secondary outcomes will include monitoring cardiovascular and respiratory effects, pain levels, sedation scores, and duration of crying.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 1-12 years who require sedation for small painful procedures in the emergency room.
Not a fit: Patients with allergies to dexmedetomidine, significant cardiac or respiratory dysfunction, or those who are critically ill may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective sedation option for children undergoing painful procedures in emergency settings.
How similar studies have performed: Other studies have shown promising results with dexmedetomidine for sedation in pediatric populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oulu
- Oulu University Hospital — Oulu, Finland (RECRUITING)
Study contacts
- Principal investigator: Outi Peltoniemi — Oulu University Hospital
- Study coordinator: Outi Peltoniemi
- Email: outi.peltoniemi@ppshp.fi
- Phone: +35883155837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Anesthesia, pediatrics, sedation, emergency room sedation, intranasal sedation, dexmedetomidine, intranasal dexmedetomidine