Pain Free Laceration Repairs Using Intra-nasal Ketamine

Laceration Clinical Trial

Official title:

Pain Free Laceration Repairs Using Intra-nasal Ketamine: A Dose Escalation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053947
• Other study ID #: 2017-1149
• Status: Completed
• Phase: Phase 2
• Start date: February 16, 2017
• Est. completion date: November 27, 2019

Study information

• Verified date: December 2019
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Laceration
• Lacerations

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Justine's Hospital	Montreal	Quebec
Canada	Sickkids	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Evelyne D.Trottier

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Anxiety before, during and after the procedure assessed with the Procedure behavioural rating revised scale.		18 months
Secondary	Sedation level during the procedure and time to return to baseline using the University of Michigan sedation scale (UMSS).		18 months
Secondary	Parents, patients and provider satisfaction with sedation as assessed by Likert scale.		18 months
Secondary	Sides effects and adverse events as assessed by the PERC/PECARN consensus criteria for procedural sedation in children.		18 months