Pain Free Laceration Repairs Using Intra-nasal Ketamine

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

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.

Study Overview

• Status: Completed
• Conditions: Laceration
• Intervention / Treatment: Drug: Intranasal Ketamine

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • SickKids
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • St. Justine's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ketamine IN; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Dose finding : determine the optimal dose of IN ketamine between a range of 3 and 9 mg/kg for laceration suture repair	18 months
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.	Dose evaluation: Evaluate the dose determined in DosINK 1 in 30 patients	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Anxiety before, during and after the procedure assessed with the Procedure behavioural rating revised scale.	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
Sides effects and adverse events as assessed by the PERC/PECARN consensus criteria for procedural sedation in children.	18 months

Collaborators and Investigators

• Sponsor: Evelyne D.Trottier
• Investigators: Principal Investigator: Evelyne D Trottier, MD, FRCPC, St. Justine's Hospital

Publications and helpful links

General Publications

• Rached-d'Astous S, Bailey B, Marquis C, Lebel D, Desjardins MP, Trottier ED. Laceration repair using intranasal ketamine: a phase 2 dose escalation clinical trial. CJEM. 2022 Apr;24(3):347-348. doi: 10.1007/s43678-021-00235-3. Epub 2021 Dec 20. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2017
• Primary Completion (Actual): November 27, 2019
• Study Completion (Actual): November 27, 2019

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Pain Management; Intranasal Ketamine
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 2017-1149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No