Intranasal Ketamine and Fracture Reduction in Pediatric Emergencies (KETAPED)
Condition: Fractures, Closed
MeSH terms: Emergencies; Fractures, Bone; Fractures, Closed
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      The incidence of child fractures is around 180 per 10,000 children under 16 years old in
      industrialized countries (Norway, Sweden, Great Britain and France). However, the rate of
      fractures treated in pediatric emergencies varies according to the different sports
      activities and the location of the hospital. In Nice, the number of fractures of the upper
      limb in children is about 400 per year, because of the sporting diversity between sea and
      mountains to which children have access.

      Most of the child's fractures are treated in operating theaters in hospitals in France.
      However, 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. At the University Hospital of Nice, analgesic management of simple fractures
      of the child, including fractures of the upper limb, combines 2 drugs: midazolam and
      nalbuphine intra-rectal. This therapy is used in combination with nitrous oxide inhalation
      for the reduction of the fracture site.

      However, this treatment is not optimal: midazolam has significant side effects (respiratory
      depressant, hypotensive, excessive drowsiness, etc.) and the intrarectal way of
      administration suggests a problem of delayed action of the administered product, causing a
      variability of the effectiveness of the drug over time and a social problem. 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. This drug is a very
      interesting choice in the treatment of analgesics in surgical emergencies. However, it is not
      used in pediatric emergencies for excessive fear of side effects and service habits.

      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 a 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 and taking into account lost sight, 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 < 4/10.

      The secondary evaluation criteria will be: the evaluation of the degree of sedation during
      the gesture by the "University of Michigan Sedation Scale" score, the evaluation of the
      tolerance of the treatment in the child during and after the gesture (presence of
      desaturation) O2 <94%, hypersialorrhea, apnea, laryngospasm), 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.
    

Intervention name(s): Ketamine Hydrochloride
Intervention type(s): Drug
Intervention description(s): intranasal use of ketamine 1mg/kg with nitrous oxide
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment