Inhalation of Nitrous Oxide, Opioid Analgesic Adverse Reaction, Pain
Conditions
Brief summary
This study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for analgosedation for short and painful procedures in children.
Detailed description
Nitrous oxide 70% (N20 70%) combined with 30% oxygen meets many criteria of an ideal pain medication for procedural analgosedation in children. At the emergency department of the Children's Hospital of Zurich, Switzerland, N20 70% is regularly used for short and painful orthopaedic procedures, mostly for reduction of dislocated forearm or finger fractures. The analgesic efficacy of N20 70% still remains controversial. Therefore, all children who are eligible for N20 70% receive additionally either fentanyl or placebo intranasal and then their behavior, level of sedation and adverse events are measured during the painful procedure. The hypothesis is that a combination of N20 70% and fentanyl intranasal is not significant better than N20 70% combined with basic analgetics.
Interventions
DRUGFentanyl intranasal
fentanyl is applied intranasally with a MAD (mucosal atomization device) prior to the application of nitrous oxide 70% analgosedation
DRUGNaCl 0.9% intranasal
Placebo is applied intranasally with a MAD (mucosal atomization device) Prior to the application of nitrous oxide 70% analgosedation
Sponsors
University Children's Hospital, Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* indication for nitrous oxide 70% application * boys/girls aged 2-16 years * informed consent
Exclusion criteria
* due to language barrier no sufficient communication possible to explain the study * incompatibility to Fentanyl Sintetica * incompatibility to morphinomimetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic efficacy of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal using the FLACC score | up to 18 months | the Patient is videotaped during the painful procedure and afterwards the video is analysed using the FLACC score. Each category is scored on a 0-2 scale (5 categories) which results in a total score of 0 (no pain) -10 (severe pain). |
Secondary
| Measure | Time frame |
|---|---|
| adverse events of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal | up to 18 months |
Countries
Switzerland
Outcome results
None listed