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Pain Free Laceration Repairs Using Intra-nasal Ketamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03053947
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Evelyne D.Trottier, St. Justine's Hospital

Tracking Information
First Submitted Date  ICMJE December 22, 2016
First Posted Date  ICMJE February 15, 2017
Last Update Posted Date December 16, 2019
Actual Study Start Date  ICMJE February 16, 2017
Actual Primary Completion Date November 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
Optimal doses 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Free Laceration Repairs Using Intra-nasal Ketamine
Official Title  ICMJE Pain Free Laceration Repairs Using Intra-nasal Ketamine: A Dose Escalation Clinical Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Laceration
Intervention  ICMJE 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.
Study Arms  ICMJE Ketamine IN
All participants will receive intranasal Ketamine between 3mg/kg up to 9 mg/kg, once.
Intervention: Drug: Intranasal Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2019)
42
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
40
Actual Study Completion Date  ICMJE November 27, 2019
Actual Primary Completion Date November 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03053947
Other Study ID Numbers  ICMJE 2017-1149
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Evelyne D.Trottier, St. Justine's Hospital
Study Sponsor  ICMJE Evelyne D.Trottier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Evelyne D Trottier, MD, FRCPC St. Justine's Hospital
PRS Account St. Justine's Hospital
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP