NCT03525821: KETAPED

Intranasal Ketamine and Fracture Reduction in Pediatric Emergencies (KETAPED)

Completed Phase 3 Last updated 6 October 2020

What this trial tests

Phase 3 trial testing Ketamine Hydrochloride in Fractures, Closed in 9 participants. Completed in 13 September 2020.

Timeline

5 July 2018

Primary endpoint
13 September 2020

13 September 2020

Quick facts

Lead sponsor	Fondation Lenval
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	5 July 2018
Primary completion	13 September 2020
Estimated completion	13 September 2020
Sites	1 location across France

Drugs / interventions tested

• Ketamine Hydrochloride — full drug profile →

Conditions studied

• Fractures, Closed — all drugs for Fractures, Closed →

Sponsor

Fondation Lenval — full company profile →

Who can join

Adults 4 to 17, any sex, with Fractures, Closed. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.