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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

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 - PAIN

Status
Unknown
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42266
Enrollment
128
Registered
2015-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dislocations fractures wounds or burns

Interventions

None listed

Sponsors

Rode Kruis Ziekenhuis
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is painseverity measured by using an age-appropriate validated pain score (VAS or WBFPS) at 10 min post-analgesia and registration of adverse events, serious events and complications.—

Secondary

MeasureTime frame
Secondairy outcome measures are - pain severity at 0, 5, 20, 30, 60 minutes after analgesia administration - time to administration - doctor/nurse satisfaction scores—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)