Nebulized Sub-dissociative Dose Ketamine at Three Different Dosing Regimens for Treating Acute Pain in the Pediatric ED

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

In the situation when intravenous access is not readily available or unobtainable, sub-dissociative dose ketamine can be administered via intranasal route (IN). The data supporting intranasal route in pediatric patients is somewhat conflicting with regards to the optimum intranasal dose (range 0.75-1 mg/kg) and frequencies of administration. Hence, another non-invasive route such as nebulization via Breath-Actuated Nebulizer which allows a controlled patient-initiated delivery of analgesics in titratable fashion might be considered in the ED. Administration of fentanyl via BAN for pediatric patients presenting to the ED with acute traumatic musculo-skeletal injuries was found to be safe and effective and comparable to intravenous fentanyl and intravenous morphine. Nebulized administration of ketamine however, has only been studied in the areas of acute postoperative pain management, cancer palliation, and status asthmaticus therapy (ref). To our knowledge, there are no prospective randomized trials that evaluated a role of nebulized SDK role in managing a variety of acute and chronic painful conditions in the ED.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Antonios Likourezos
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• Patients with ages between 7 and 17 presenting to the ED

• with acute painful conditions; score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.

• traumatic and non-traumatic abdominal pain

• flank pain

• back ,pain

• musculoskeletal pain,

• vaso-occlusive painful crisis of sickle cell disease, and lacerations with a

• Patients receiving oral acetaminophen and/or ibuprofen at triage prior to SDK administration

Exclusion Criteria:

• 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