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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: Evelyne D.Trottier

Current Primary Outcome: Optimal doses 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • Anxiety before, during and after the procedure assessed with the Procedure behavioural rating revised scale. [ Time Frame: 18 months ]
  • Sedation level during the procedure and time to return to baseline using the University of Michigan sedation scale (UMSS). [ Time Frame: 18 months ]
  • Parents, patients and provider satisfaction with sedation as assessed by Likert scale. [ Time Frame: 18 months ]
  • Sides effects and adverse events as assessed by the PERC/PECARN consensus criteria for procedural sedation in children. [ Time Frame: 18 months ]


Original Secondary Outcome: Same as current

Information By: St. Justine's Hospital

Dates:
Date Received: December 22, 2016
Date Started: February 16, 2017
Date Completion: June 2019
Last Updated: February 15, 2017
Last Verified: February 2017