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Pain Free Laceration Repairs Using Intra-nasal Ketamine

Primary Purpose

Laceration

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Intranasal Ketamine
Sponsored by
Evelyne D.Trottier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laceration focused on measuring Intranasal Ketamine, Pain Management

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sickkids
  • St. Justine's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ketamine IN

Arm Description

All participants will receive intranasal Ketamine between 3mg/kg up to 9 mg/kg, once.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2016
Last Updated
December 12, 2019
Sponsor
Evelyne D.Trottier
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1. Study Identification

Unique Protocol Identification Number
NCT03053947
Brief Title
Pain Free Laceration Repairs Using Intra-nasal Ketamine
Official Title
Pain Free Laceration Repairs Using Intra-nasal Ketamine: A Dose Escalation Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
November 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Evelyne D.Trottier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laceration
Keywords
Intranasal Ketamine, Pain Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine IN
Arm Type
Other
Arm Description
All participants will receive intranasal Ketamine between 3mg/kg up to 9 mg/kg, once.
Intervention Type
Drug
Intervention Name(s)
Intranasal Ketamine
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
Dose finding : determine the optimal dose of IN ketamine between a range of 3 and 9 mg/kg for laceration suture repair
Time Frame
18 months
Title
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.
Description
Dose evaluation: Evaluate the dose determined in DosINK 1 in 30 patients
Time Frame
18 months
Secondary Outcome Measure Information:
Title
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
Title
Anxiety before, during and after the procedure assessed with the Procedure behavioural rating revised scale.
Time Frame
18 months
Title
Sedation level during the procedure and time to return to baseline using the University of Michigan sedation scale (UMSS).
Time Frame
18 months
Title
Parents, patients and provider satisfaction with sedation as assessed by Likert scale.
Time Frame
18 months
Title
Sides effects and adverse events as assessed by the PERC/PECARN consensus criteria for procedural sedation in children.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelyne D Trottier, MD, FRCPC
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sickkids
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
St. Justine's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34928491
Citation
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.
Results Reference
derived

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Pain Free Laceration Repairs Using Intra-nasal Ketamine

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