Pediatric Analgesia via the Intra-Nasal route. An observational multicenter prospective cohort study of atomized intranasal fentanyl in pediatric trauma patients in the emergency department

Phase 4

Withdrawn

• Conditions: dislocations; fractures; wounds or burns; 10005942

• Registration Number: NL-OMON42266
• Lead Sponsor: Rode Kruis Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 128

Inclusion Criteria

Pediatric traumapatients >2yrs in the Emergency Department
Pain due to fractures, dislocations, wounds or burns
Receiving intranasal fentanyl

Exclusion Criteria

Children younger than 2 yrs
No administration of intranasale fentanyl because of nasal obstruction, nose bleed or allergy for fentanyl
Legal guardian not able to sign informed consent

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is painseverity measured by using an<br /><br>age-appropriate validated pain score (VAS or WBFPS) at 10 min post-analgesia<br /><br>and registration of adverse events, serious events and complications.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondairy outcome measures are<br /><br>- pain severity at 0, 5, 20, 30, 60 minutes after analgesia administration<br /><br>- time to administration<br /><br>- doctor/nurse satisfaction scores</p><br>