IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair

Stopped early · Phase 4

Conditions studied: Laceration of Skin

In brief

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.

Key facts

Study ID

NCT03528512

Run by

Corewell Health East

People needed

5

Starts

2018-09-04

Expected to finish

2019-02-06

Last updated by the study team

2021-08-24

Who can join

Age: 1 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Beaumont Hospital - Royal Oak — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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