Pain Free Laceration Repairs Using Intra-nasal Ketamine

Phase 2

Completed

• Conditions: Laceration
• Interventions: Drug: Intranasal Ketamine

• Registration Number: NCT03053947
• Lead Sponsor: Evelyne D.Trottier

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2017-02-14
• Study First Posted: 2017-02-15
• Study Start: 2017-02-16
• Primary Completion: 2019-11-27
• Study Completion: 2019-11-27
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine IN	Intranasal Ketamine	All participants will receive intranasal Ketamine between 3mg/kg up to 9 mg/kg, once.

Primary Outcome Measures

Name	Time	Method
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.	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.	18 months	Dose evaluation: Evaluate the dose determined in DosINK 1 in 30 patients

Secondary Outcome Measures

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

Trial Locations

Locations (2)

St. Justine's Hospital; 🇨🇦 Montreal, Quebec, Canada

Sickkids; 🇨🇦 Toronto, Ontario, Canada