A Phase 3 interventional study of Ketamine Hydrochloride in Fractures, Closed, sponsored by Fondation Lenval. Completed at 1 site in France. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-10-06.
Sponsored by Fondation Lenval · Phase 3, Interventional, and Treatment
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.
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.
44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.
This study's enrollment of 9 is below the median of 45 across 34 interventional studies indexed under Fractures, Closed.
Browse Fractures, Closed studies →Fondation Lenval is the lead sponsor of 61 studies on the registry; 18 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
intranasal adminstration of ketamine combined with nitrous oxide befor reduction of fracture
Drug: Ketamine Hydrochloride
intranasal use of ketamine 1mg/kg with nitrous oxide
effectiveness evaluation of ketamine by measure the change of pain control
The effectiveness of ketamine will be assessed by measuring the change of pain control between the baseline and after fracture reduction. Measurement of pain intensity will be carried out using the Face, Legs, Activity, Cry, Consolability scale (FLACC) 5-item hetero-evaluation of pain, validated in children. The FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. Effective pain control will be defined by a score obtained with the FLACC \<4/10 scale during reduction and after reduction. Our criterion will therefore be binary: control or not control of pain.
Time frame: 5 minutes before the admintration of the ketamine and 15 min and 30 min after the administration of the ketamine
evaluation of the degree of sedation
The evaluation of the degree of sedation will be made 5 minutes after the administration of the ketamine by the internationally validated anesthetic score "University of Michigan Sedation Scale" based on 5 items ranging from the state of awakening to no response to stimulation. The level of sedation sought is a score equal to 1 corresponding to a relaxed / sleeping patient and having an appropriate response to the weak stimulation.
Time frame: 5 minutes after the administration of the ketamine
evaluation of tolerance
Treatment tolerance in children will be assessed through the collection of adverse reactions for the duration of the procedure, from the introduction of sedation to the end of the post-reduction period . Possible side effects are listed in "Undesirable Events" section in CRF. For each adverse event, the patient rate with at least one occurrence of the effect should be determined.
Time frame: from time of ketamine administration to the end of patient participation of study, for about 3 hours
evaluation of child's feeling of pain
The assessment of the child's feeling of pain after the reduction will be carried out by a closed question: "Have you had any pain?" Possible answers: No, Yes a little, Yes a lot
Time frame: after the reduction during 2 hours
The nurse's assessment of preparation feasibility of ketamine
The nurse's assessment of the feasibility of the preparation of the medicinal product will be based on a questionnaire based on two closed questions on the timeliness of drug preparation : "Are you satisfied with the speed of preparation of intranasal ketamine? " Answers: Not satisfied, Partially satisfied, Satisfied, Very satisfied
Time frame: 30 minutes after the preparation of the treatment
The nurse's assessment of administration feasibility of ketamine
The nurse's assessment of the feasibility of the administration of the medicinal product will be based on a questionnaire based on two closed questions on the ease of administration of the drug intranasally: Are you satisfied with the ease of administration of intranasal ketamine? " Answers: Not satisfied, Partially satisfied, Satisfied, Very satisfied
Time frame: 30 minutes after the administration of the treatment
Ran from Jul 2018 to primary completion in Sep 2020, 26 months.
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Studies of the drug tested here: Ketamine
Fondation Lenval