IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair
Condition: Laceration of Skin
MeSH terms: Lacerations
Intervention: Ketamine; Midazolam and fentanyl
Intervention description: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml); Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
Intervention MeSH terms: Midazolam; Fentanyl; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double blinded control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: A randomization list created by an online randomization tool will be used to assign participants to a treatment arm (in random blocks of 4, 6, and 8). As participants are enrolled in the study, they will be assigned to the next available sequential treatment arm.
Enrollment: 5.0
Sex: All
Minimum age: 6 Months
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Pediatric; analgesia; pain control; sedation; intranasal ketamine; intranasal midazolam; intranasal fentanyl

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.
    

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