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Completed

NCT Number: NCT03053947

Pain Free Laceration Repairs Using Intra-nasal Ketamine

Lacerations are one of most common trauma in children presenting to the emergency department (ED). Currently, there are wide variations regarding sedation and analgesia practices when suture are required. Even though topical anesthesia is very useful to reduce pain, it does not obviate the use of pharmacologic agents to decrease stress in anxious children undergoing laceration repairs in the ED.

There is a growing interest in the intranasal (IN) route of administration in the pediatric population. It bypasses the first hepatic passage and thus provides medications direct access to the systemic circulation leading to higher and faster serum concentrations than would the oral route. Also, intravenous (IV) cannulation can be avoided reducing the pain associated with it and the need for nursing time and procedure delay. IN fentanyl and midazolam are two agents that can be combined for this procedure, but respiratory depression is a feared adverse effects. Ketamine is the most commonly used IV agent for procedural sedation, and can offer potent analgesia and sedation while maintaining respiratory drive and protective airway reflexes. Few studies have evaluated IN ketamine for procedural sedation. There is a wide range of dosing reported from 3 to 9 mg/kg. This raises the question as what is the lowest possible dosage that can be used to successfully repairs laceration in children with minimal restrain and no adverse events, as described by the Pediatric Emergency Research Canada (PERC)/ Pediatric Emergency Care Applied Research Network (PECARN) consensus.

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Key information

Conditions

Laceration Agnosia Lacerations Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Wounds and Injuries

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sickkids, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 1 to 12 years;
  • Weight between 10 and 30 kg
  • Any laceration requiring sutures repair;
  • Need for procedural sedation according to the emergency physician assessment for the suture repair

Exclusion criteria

  • American Society of Anesthesiologists (ASA) physical status class III and more;
  • Previous administration of IV, IN or oral analgesics or opioid other than acetaminophen and ibuprofen;
  • Allergy or previous adverse reaction to ketamine;
  • Aberrant nasal anatomy or nasal trauma;
  • Presence of multiple trauma or eye rupture suspicion
  • Head injury with loss of consciousness, decreased Glasgow Coma Scale (GCS) or intracranial bleeding;
  • Cognitive impairment;
  • Known glaucoma;
  • Pregnancy
  • Language barrier
  • Known schizophrenia or psychotic event;
  • Uncontrolled hypertension;
  • Airway instability (tracheal surgery, tracheal stenosis, tracheomalacia, and laryngomalacia)
  • Active pulmonary infections (including upper respiratory infections)
  • Known or suspected cardiac disease
  • Known or suspected kidney disease

Treatment and study plan

Intranasal ketamine

Drug

Administration of intranasal ketamine at a dose from 3 to 9 mg/kg for safe and effective procedural sedation for laceration repair in the ED for children aged 1 to 12 year-old.

Primary outcomes

  1. DosINK 1-Optimal dose of intranasal ketamine for adequate procedural sedation as assessed by the PERC/PECARN consensus criteria for procedural sedation in children during their laceration repair.

    Time frame: 18 months

    Dose finding : determine the optimal dose of IN ketamine between a range of 3 and 9 mg/kg for laceration suture repair

  2. DosINK 2- Evaluation of the dose determined in DosINK 1 of intranasal ketamine for adequate procedural sedation as assessed by the PERC/PECARN consensus criteria for procedural sedation in children during their laceration repair.

    Time frame: 18 months

    Dose evaluation: Evaluate the dose determined in DosINK 1 in 30 patients

Secondary outcomes

  1. Pain before, during and after the procedure assessed with the Faces pain scale Revised for children older than 4 year-old and with the Face Legs Activity Cry Consolability (FLACC) score for children younger than 4 year-old.

    Time frame: 18 months

  2. Anxiety before, during and after the procedure assessed with the Procedure behavioural rating revised scale.

    Time frame: 18 months

  3. Sedation level during the procedure and time to return to baseline using the University of Michigan sedation scale (UMSS).

    Time frame: 18 months

  4. Parents, patients and provider satisfaction with sedation as assessed by Likert scale.

    Time frame: 18 months

  5. Sides effects and adverse events as assessed by the PERC/PECARN consensus criteria for procedural sedation in children.

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Evelyne D.Trottier

Other

Registry information

Official study title

Pain Free Laceration Repairs Using Intra-nasal Ketamine: A Dose Escalation Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2017
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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