Intranasal Ketamine and Fracture Reduction in Pediatric Emergencies (KETAPED)

NCT03525821 | Completed Phase 3

• 1 other identifier: 17-HPNCL-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Closed

Outcome Measures

Primary Outcomes (1)

• 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.

  5 minutes before the admintration of the ketamine and 15 min and 30 min after the administration of the ketamine

Secondary Outcomes (5)

• evaluation of the degree of sedation

  5 minutes after the administration of the ketamine

• evaluation of tolerance

  from time of ketamine administration to the end of patient participation of study, for about 3 hours

• evaluation of child's feeling of pain

  after the reduction during 2 hours

• The nurse's assessment of preparation feasibility of ketamine

  30 minutes after the preparation of the treatment

• The nurse's assessment of administration feasibility of ketamine

  30 minutes after the administration of the treatment

Study Arms (1)

intranasal administration of ketamine

EXPERIMENTAL

intranasal adminstration of ketamine combined with nitrous oxide befor reduction of fracture

Drug: Ketamine Hydrochloride

Interventions

Ketamine Hydrochloride DRUG

intranasal use of ketamine 1mg/kg with nitrous oxide

intranasal administration of ketamine

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or Female Children
• Aged 4 to 17 years old
• Presenting a fracture isolated from the distal end of the upper limb with closed focus, requiring a reduction
• Fracture dating from \<72h
• stable hemodynamics
• Affiliation to a social security scheme
• Signature of the authorization documents of the 2 parents or the representative of the parental authority for the participation of the child in the study
• Signature of informed consent for children over 15 years of age

You may not qualify if:

• Known hypersensitivity to ketamine
• History of epilepsy or known psychiatric illness
• Any child with a developing respiratory disease (asthma, laryngitis, tracheitis)
• Any child who has received an analgesic of level 2 or 3 in the 3 hours preceding the treatment in pediatric emergencies
• High Blood Pressure
• Severe Heart Failure
• polytrauma
• Open fracture
• Proven pregnancy
• Any child requiring pure oxygen ventilation.
• Nitrous oxide should not be used in situations at risk of accumulation in cavities and when its expansion could be dangerous, such as cranial trauma with alteration of the state of consciousness, maxillofacial trauma, pneumothorax, gas embolism , bullous emphysema, sinus or middle ear surgery, internal ear surgery, severe abdominal distension (eg, bowel occlusion)
• A child who has recently received an ophthalmic gas (SF6, C3F8, C2F6) used in ocular surgery as long as a gas bubble persists inside the eye and at a minimum for a period of 3 months. Severe post-operative complications may occur in relation to increased intraocular pressure

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hôpitaux pédiatriques de Nice CHU-Lenval

Nice, 06200, France

Location

MeSH Terms

Conditions

Fractures, Closed

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Anne-Laure HERISSE, MD

  Hôpitaux Pédiatriques de Nice CHU-LENVAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 16, 2018
• Study Start: July 5, 2018
• Primary Completion: September 13, 2020
• Study Completion: September 13, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

FR (1)