Pain Free Laceration Repairs Using Intra-nasal Ketamine

NCT ID: NCT03053947

Last Updated: 2019-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-16
• Study Completion Date: 2019-11-27

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.

Conditions

Laceration

Keywords

Intranasal Ketamine; Pain Management

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketamine IN

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

Group Type: OTHER

Intranasal Ketamine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evelyne D.Trottier

OTHER

Sponsor Role: lead

Responsible Party

Evelyne D.Trottier

M.D., FRCPC

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Evelyne D Trottier, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

Sickkids

Toronto, Ontario, Canada

St. Justine's Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36774905 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34928491 (View on PubMed)

Other Identifiers

2017-1149

Identifier Type: -

Identifier Source: org_study_id