Primary objective:Our primary objective is to determine if the intranasal (IN) route is an effective, safe and quick alternative for intravenous fentanyl to treat acute pain in emergency department pediatric traumapatients. Secondary objectives:To…
ID
Source
Brief title
Condition
- Bone and joint injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondairy outcome measures are
- pain severity at 0, 5, 20, 30, 60 minutes after analgesia administration
- time to administration
- doctor/nurse satisfaction scores
Background summary
Pain in traumapatients causes anxiousness and distress; it interferes with
recovery and cure. Administrating adequate painrelief like intravenous
fentanyl, can be challenging and painful for the patient. To avoid the
intravenous route, fentanyl can also be administered via nasal spray.
Our hypothesis is that intranasal fentanyl will provide adequate painrelief and
is safe in children with fractures, dislocations, wounds or burns in the
emergency department.
Study objective
Primary objective:
Our primary objective is to determine if the intranasal (IN) route is an
effective, safe and quick alternative for intravenous fentanyl to treat acute
pain in emergency department pediatric traumapatients.
Secondary objectives:
To determine how fast the time to treatment is via the intranasal route
To determine the satisfaction scores of the nurse/doctor administering the
intranasal fentanyl.
Study design
Multi-centre observational cohort study
Study burden and risks
Participation in the study brings nog additional risks for the patient.
Burdens associated with the study is a 60 minute stay in the Emergency
department with monitoring and asking the painscore of the patient.
Vondellaan 13
Beverwijk 1942LE
NL
Vondellaan 13
Beverwijk 1942LE
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-003214-85-NL |
| CCMO | NL49994.094.14 |