Intranasal Ketamine and Fracture Reduction in Pediatric Emergencies (KETAPED)
Status:
Completed
Trial end date:
2020-09-13
Target enrollment:
Participant gender:
Summary
The incidence of child fractures is around 180 per 10,000 children under 16 years old in
industrialized countries. More and more hospitals, such as Nice University Hospital, are
using vigilant procedural sedation for simple surgical procedures such as fracture reduction,
allowing ambulatory care. This is why the investigators propose the alternative of intranasal
ketamine associated with nitrous oxide inhalation in the management of children's pain.
Indeed, thanks to its short duration of action and short duration of effectiveness, ketamine
is already used in pediatric anesthesia and resuscitation for many years and is considered
safe and effective.
The objective of this work is to evaluate the efficacy of intranasal ketamine associated with
nitrous oxide inhalation in the reduction of isolated fractures from the extremity of the
upper limb in children allowing optimal management.
This work will consist of research involving non-randomized, monocentric prospective
interventional category 1 for duration of 18 months. Patients over 4 years of age and under
18 years, with a closed fracture isolated from the distal extremity of the upper limb, with
stable hemodynamic will be included. In view of active queue of pediatric emergencies Nice
University Hospital, the investigators can include 60 patients, allowing to have a
representative sample of the pediatric population.
The treatment administered will be intranasal ketamine, using a tip MAD® (Mucosal Atomization
Device) at a dosage of 1 mg/kg in a single administration, under continuous cardiorespiratory
monitoring for 2 hours. The reduction of the fracture will be done under inhalation of
nitrous oxide. The primary endpoint will be pain control during and after fracture reduction,
defined by the FLACC Hetero-Assessment Pain Rating Scale. Others parameters as the evaluation
of the degree of sedation, evaluation of the child's feeling of pain after the reduction,
evaluation of the feasibility of the preparation and administration of the drug by the nurse
will be reported.