Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
402 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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