IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair

Children frequently present to pediatric emergency center (PEC) with cuts of different body
parts. Often, repair of the cuts (laceration repair) proves to be traumatic for the children
and the parents alike. Ideally, repair of the cuts should be as painless and free from
anxiety as possible. To work towards this goal, different analgesic (pain drugs) and sedative
( to calm patients down) management strategies use intravenous (into the vein), intramuscular
( into the muscle) and, more recently, intranasal (into the nostrils) routes. Unfortunately,
intravenous access is hard to establish and may be painful for the child. The intramuscular
route is often similarly painful. Due to the rich blood supply and large surface area of the
nasal vestibule, intranasally (IN) administered medications are highly absorbed. IN
approaches for procedural pain reduction, such as during dental work, have been demonstrated
to make drug administration painless and well tolerated, making it an attractive potential
alternative to commonly used intravenous and intramuscular approaches. In several small
research studies, high doses of intranasal ketamine (9 mg/kg) produce adequate sedation
during laceration repair with minimal side effects. A recent study compared IN ketamine,
midazolam, fentanyl or combination of these drugs for pain management and urgent analgesia
sedation, and demonstrated that they are effective and safe, reporting that ~60% of study
participants sustained mild to moderate sedation. Unfortunately, there are not enough studies
done to evaluate the sedation effect of IN ketamine for laceration repair. Small studies
(Tsze and Nemeth) showed that IN ketamine is an effective alternative but no studies are done
to compare combination IN midazolam and fentanyl to IN ketamine. Our null hypothesis is that
there is no difference in sedation scores during laceration repair when comparing the use of
IN ketamine to IN midazolam and IN fentanyl.

We will recruit a total of 30 pediatric patients (6 months - 10 y age) in a randomized
double-blinded pilot study of IN ketamine alone or combined IN midazolam and IN fentanyl for
laceration repair, comparing levels of pain and sedation scores using validated pediatric
metrics as the primary outcomes. In addition, we will assess comparative nurse and physician
satisfaction in each of these two groups. Understanding the relative effectiveness of these
two approaches will help us identify a safe, effective, and easily administrable method to
manage pain and anxiety, thereby, improving patient experience and outcomes during the often
traumatic laceration repair procedure.

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