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Pain Free Laceration Repairs Using Intra-nasal Ketamine

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ClinicalTrials.gov Identifier: NCT03053947
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Evelyne D.Trottier, St. Justine's Hospital

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.


Condition or disease Intervention/treatment Phase
Laceration Drug: Intranasal Ketamine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Free Laceration Repairs Using Intra-nasal Ketamine: A Dose Escalation Clinical Trial
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Ketamine

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
  2. Anxiety before, during and after the procedure assessed with the Procedure behavioural rating revised scale. [ Time Frame: 18 months ]
  3. Sedation level during the procedure and time to return to baseline using the University of Michigan sedation scale (UMSS). [ Time Frame: 18 months ]
  4. Parents, patients and provider satisfaction with sedation as assessed by Likert scale. [ Time Frame: 18 months ]
  5. Sides effects and adverse events as assessed by the PERC/PECARN consensus criteria for procedural sedation in children. [ Time Frame: 18 months ]


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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053947


Contacts
Contact: Evelyne D Trottier, MD, FRCPC 514 345 4931 ext 5060 evelynedtrottier@gmail.com
Contact: Maryse Lagace, BSN, CCRP 514 354 4931 ext 3640 maryse.lagace@recherche-ste-justine.qc.ca

Locations
Canada, Ontario
Sickkids Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Maggie Rumantir       maggie.rumantir@sickkids.ca   
Principal Investigator: Yaron Finkelstein, Dr         
Canada, Quebec
St. Justine's Hospital Recruiting
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Evelyne D.Trottier
Investigators
Principal Investigator: Evelyne D Trottier, MD, FRCPC St. Justine's Hospital

Responsible Party: Evelyne D.Trottier, M.D., FRCPC, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03053947     History of Changes
Other Study ID Numbers: 2017-1149
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Evelyne D.Trottier, St. Justine's Hospital:
Intranasal Ketamine
Pain Management

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action