Pain Free Laceration Repairs Using Intra-nasal Ketamine

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.

Intervention / Treatment

  • Drug: intranasal ketamine

Condition or Disease

  • Laceration

Phase

Study Design

Study type: Interventional
Status: Completed
Study results: No Results Available
Age: 1 Year to 12 Years   (Child)
Enrollment: 42 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Feb 16, 2017
Primary Completion: Nov 27, 2019
Completion Date: Nov 27, 2019
Study First Posted: Feb 15, 2017
Results First Posted: Aug 31, 2020
Last Updated: Dec 16, 2019

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Eligibility Criteria

Sex: All
Minimum Age: 1
Maximum Age: 12

More Details

NCT Number: NCT03053947
Other IDs: 2017-1149
Study URL: https://ClinicalTrials.gov/show/NCT03053947
Last updated: Jun 17, 2022