Comparison of Nebulized Sub-dissociative Dose Ketamine at Three Different Dosing Regimens for Treating Acute Pain in the Pediatric ED: A Prospective, Randomized Double-Blind Trial

STUDY DESIGN Subjects: Pediatric patients aged 7-17 years presenting to the ED with acute painful conditions such as traumatic and non-traumatic abdominal, flank, back, musculoskeletal pain, vaso-occlusive painful crisis of sickle cell disease, and lacerations with a pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale and requiring sub-dissociative dose ketamine analgesia as determined by the treating attending physician. Eligible patients will be identified by the primary evaluation of the treating physician, who believes that the patient will benefit from the non-invasive route of Breath Actuated Nebulized (BAN) Sub-Dissociative Dose Ketamine rather than other methods (Intravenous, oral etc.) The treating physician will inform the research team of the potential patient to begin the consenting and enrollment process.

Patients' screening and enrollment will be performed by study investigators and research assistants. All patients will be enrolled at various times of the day when study investigators will be available for patient enrollment and ED pharmacists will be available for medication preparation.

Eligibility Criteria: Patients with ages between 7 and 17 presenting to the ED with acute painful conditions such as traumatic and non-traumatic abdominal, flank, back, musculoskeletal pain, vaso-occlusive painful crisis of sickle cell disease, and lacerations with a score of 5 or more on a standard 11- point (0 to 10) numeric rating scale. Patients receiving oral acetaminophen and/or ibuprofen at triage prior to SDK administration will be eligible for the study.

Exclusion criteria will include altered mental status, GCS<15, allergy to ketamine, pregnant patients, weight greater than 100 kg, heart rate >180, airway abnormalities ( congenital or acquired), absence of parent(s) at the time of consent, closed head injury, seizure disorder, use of opioid analgesics, schizophrenia or bipolar disorder.

Design: This is a prospective, randomized, double-blind trial comparing analgesic efficacy and safety of nebulized SDK administered at three different doses to pediatric patients presenting to the ED of Maimonides Medical Center with acute painful conditions. Upon meeting the eligibility criteria, patients will be randomized into one of three study arms based on the dosing of the SDK: 0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg.