IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair

• Status: Terminated
• Trial end date: 2019-02-06
• Target enrollment: 0
• Participant gender: All

Summary

Often, repair of the cuts (laceration repair) proves to be traumatic for the children and the parents. Nasal spray (Intranasal/IN) approaches for procedural pain reduction, such as during dental work, have been demonstrated to make drug administration painless and well tolerated. We are comparing IN ketamine to IN midazolam and fentanyl for pain and reducing anxiety during repair of cuts in children.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Beaumont Hospitals
• Treatments: Fentanyl; Ketamine; Midazolam

Criteria

Inclusion Criteria:

• Pediatric patients 6 months to 10 years who required laceration repair in the pediatric emergency center.

• Laceration should be less than 5 cm long, require 2 or more sutures and no consult subspeciality consult for repair.

• Topical anesthetic (lidocaine-epinephrine-tetracaine topical solution/XAP) will be applied to all lacerations for 20 minutes duration before giving the intranasal medications.

Exclusion Criteria:

• Age < 6 months

• Documented allergy or adverse effect to ketamine, midazolam or fentanyl

• Epistaxis

• Partial upper airway obstruction

• Oxygen requirement via nasal cannula

• Acute mental status changes (e.g. obtunded or somnolent)

• Documented increased intracranial pressure or increased ocular pressure

• Documented porphyria

• Previously involved in the study

• Parent or patient refusal

• Acutely compromised vitals (hypotension, desaturations, respiratory distress)

• Any known heart disease

• If any previous opioid use for analgesia during the visit

• Need for staples

• Scalp wounds

• General trauma requiring additional sedation

• Patients who received pain medications (acetaminophen or ibuprofen) before laceration repair