NCT03053947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2017

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 16, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2019

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

2.8 years

First QC Date

December 22, 2016

Last Update Submit

December 12, 2019

Conditions

Laceration

Keywords

Intranasal KetaminePain Management

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

Ketamine IN

OTHER

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

Drug: Intranasal Ketamine

Interventions

Intranasal KetamineDRUG

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.

Ketamine IN

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sickkids

Toronto, Ontario, M5G 1X8, Canada

Location

St. Justine's Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (2)

  • Rached-d'Astous S, Finkelstein Y, Bailey B, Marquis C, Lebel D, Desjardins MP, Trottier ED. Intranasal ketamine for procedural sedation in children: An open-label multicenter clinical trial. Am J Emerg Med. 2023 May;67:10-16. doi: 10.1016/j.ajem.2023.01.046. Epub 2023 Jan 30.

    PMID: 36774905DERIVED

  • 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.

    PMID: 34928491DERIVED

MeSH Terms

Conditions

LacerationsAgnosia

Condition Hierarchy (Ancestors)

Wounds and InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Evelyne D Trottier, MD, FRCPC

    St. Justine's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D., FRCPC

Study Record Dates

First Submitted

December 22, 2016

First Posted

February 15, 2017

Study Start

February 16, 2017

Primary Completion

November 27, 2019

Study Completion

November 27, 2019

Last Updated

December 16, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)