TerminatedPhase 4ketamine

IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair

NCT ID

NCT03528512

Target Enrollment

5 participants

Start Date

2018-09-04

Est. Completion

2019-02-06

About This Study

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.

Conditions Studied

Laceration of Skin

Interventions

•Ketamine
•Midazolam and fentanyl

Eligibility

Age:6 Months - 10 Years

Healthy Volunteers:No

View full eligibility 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

Study Locations (1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States