Phase 4
Completed N=80
Nebulized Sub-dissociative Dose Ketamine at Three Different Dosing Regimens for Treating Acute Pain in the Pediatric ED
Source: ClinicalTrials.gov NCT03950817 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Pain Score Reduction From Baseline — 3.5; 3.2; 3.7 pain score
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score Reduction From Baseline |
3.5; 3.2; 3.7 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03950817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.