Intranasal Ketamine and Fracture Reduction in Pediatric Emergencies (KETAPED) (KETAPED)
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ClinicalTrials.gov Identifier: NCT03525821 |
Recruitment Status :
Completed
First Posted : May 16, 2018
Last Update Posted : October 6, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | April 20, 2018 | ||||
First Posted Date ICMJE | May 16, 2018 | ||||
Last Update Posted Date | October 6, 2020 | ||||
Actual Study Start Date ICMJE | July 5, 2018 | ||||
Actual Primary Completion Date | September 13, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
effectiveness evaluation of ketamine by measure the change of pain control [ Time Frame: 5 minutes before the admintration of the ketamine and 15 min and 30 min after the administration of the ketamine ] 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.
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Original Primary Outcome Measures ICMJE |
effectiveness evaluation of ketamine [ Time Frame: 5 minutes before the admintration of the ketamine and 15 min and 30 min after the administration of the ketamine ] The effectiveness of ketamine will be assessed by measuring pain control during 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.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Intranasal Ketamine and Fracture Reduction in Pediatric Emergencies (KETAPED) | ||||
Official Title ICMJE | Intranasal Ketamine Use in the Management of Upper Limb's Fracture Reduction in Pediatric Emergencies | ||||
Brief 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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Fractures, Closed | ||||
Intervention ICMJE | Drug: Ketamine Hydrochloride
intranasal use of ketamine 1mg/kg with nitrous oxide
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Study Arms ICMJE | Experimental: intranasal administration of ketamine
intranasal adminstration of ketamine combined with nitrous oxide befor reduction of fracture
Intervention: Drug: Ketamine Hydrochloride
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
9 | ||||
Original Estimated Enrollment ICMJE |
60 | ||||
Actual Study Completion Date ICMJE | September 13, 2020 | ||||
Actual Primary Completion Date | September 13, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 4 Years to 17 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03525821 | ||||
Other Study ID Numbers ICMJE | 17-HPNCL-01 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Fondation Lenval | ||||
Study Sponsor ICMJE | Fondation Lenval | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Fondation Lenval | ||||
Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |