Pain Free Laceration Repairs Using Intra-nasal Ketamine
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|ClinicalTrials.gov Identifier: NCT03053947|
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : September 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Laceration||Drug: Intranasal Ketamine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pain Free Laceration Repairs Using Intra-nasal Ketamine: A Dose Escalation Clinical Trial|
|Actual Study Start Date :||February 16, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
All participants will receive intranasal Ketamine between 3mg/kg up to 9 mg/kg, once.
Drug: Intranasal Ketamine
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.
- 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
- 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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053947
|Contact: Evelyne D Trottier, MD, FRCPC||514 345 4931 ext firstname.lastname@example.org|
|Contact: Maryse Lagace, BSN, CCRP||514 354 4931 ext email@example.com|
|Sickkids||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Maggie Rumantir firstname.lastname@example.org|
|Principal Investigator: Yaron Finkelstein, Dr|
|St. Justine's Hospital||Recruiting|
|Montreal, Quebec, Canada, H3T 1C5|
|Principal Investigator:||Evelyne D Trottier, MD, FRCPC||St. Justine's Hospital|