Pain Free Laceration Repairs Using Intra-nasal Ketamine

Evelyne D.Trottier

Status and phase: Completed; Phase 2

Conditions: Laceration

Treatments: Drug: Intranasal Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03053947

2017-1149

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Ketamine IN

Other group

Description:

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

Treatment:

Drug: Intranasal Ketamine