Trial Outcomes & Findings for Nebulized Sub-dissociative Dose Ketamine at Three Different Dosing Regimens for Treating Acute Pain in the Pediatric ED (NCT NCT03950817)
NCT ID: NCT03950817
Last Updated: 2025-11-12
Results Overview
The primary outcome will include a comparative reduction in pain scores on numeric rating pain scale (NRS) between recipients of nebulized SDK given at three different doses at 15 minutes after analgesic administration. The Visual Analog Scale Ranges from 0 (no pain) to 10 (bery severe pain) with 5 being moderate pain. (Pain score at Baseline - Pain Score at 15 minutes)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
15 minutes
Results posted on
2025-11-12
Participant Flow
Participant milestones
| Measure |
0.75 mg/kg
The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses of 0.75 mg/kg sub-dissociative dose ketamine (SDK) to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.
Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg: Nebulized Sub-dissociative Dose Ketamine at 0.75 mg/kg
|
SDK: 1 mg/kg
The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses 1 mg/kg sub-dissociative dose ketamine (SDK), to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.
Nebulized Sub-dissociative Dose Ketamine at 1 mg/kg: Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg.
|
SDK: 1.5 mg/kg.
The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses of 1.5 mg/kg sub-dissociative dose ketamine (SDK), to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.
Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.: Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
27
|
|
Overall Study
COMPLETED
|
23
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
0.75 mg/kg
n=26 Participants
The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses of 0.75 mg/kg sub-dissociative dose ketamine (SDK) to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.
Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg: Nebulized Sub-dissociative Dose Ketamine at 0.75 mg/kg
|
SDK: 1 mg/kg
n=27 Participants
The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses 1 mg/kg sub-dissociative dose ketamine (SDK), to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.
Nebulized Sub-dissociative Dose Ketamine at 1 mg/kg: Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg.
|
SDK: 1.5 mg/kg.
n=27 Participants
The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses of 1.5 mg/kg sub-dissociative dose ketamine (SDK), to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.
Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.: Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
26 Participants
n=26 Participants
|
27 Participants
n=27 Participants
|
27 Participants
n=27 Participants
|
80 Participants
n=80 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=80 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=80 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=26 Participants
|
12 Participants
n=27 Participants
|
8 Participants
n=27 Participants
|
27 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=26 Participants
|
15 Participants
n=27 Participants
|
19 Participants
n=27 Participants
|
53 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
26 participants
n=26 Participants
|
27 participants
n=27 Participants
|
27 participants
n=27 Participants
|
80 participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 15 minutesThe primary outcome will include a comparative reduction in pain scores on numeric rating pain scale (NRS) between recipients of nebulized SDK given at three different doses at 15 minutes after analgesic administration. The Visual Analog Scale Ranges from 0 (no pain) to 10 (bery severe pain) with 5 being moderate pain. (Pain score at Baseline - Pain Score at 15 minutes)
Outcome measures
| Measure |
0.75 mg/kg
n=26 Participants
The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses of 0.75 mg/kg sub-dissociative dose ketamine (SDK) to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.
Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg: Nebulized Sub-dissociative Dose Ketamine at 0.75 mg/kg
|
SDK: 1 mg/kg
n=26 Participants
The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses 1 mg/kg sub-dissociative dose ketamine (SDK), to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.
Nebulized Sub-dissociative Dose Ketamine at 1 mg/kg: Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg.
|
SDK: 1.5 mg/kg.
n=26 Participants
The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses of 1.5 mg/kg sub-dissociative dose ketamine (SDK), to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.
Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.: Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.
|
|---|---|---|---|
|
Pain Score Reduction From Baseline
|
3.5 pain score
Standard Deviation 2.12
|
3.2 pain score
Standard Deviation 2.8
|
3.7 pain score
Standard Deviation 2.1
|
Adverse Events
0.75 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SDK: 1 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SDK: 1.5 mg/kg.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sergey Motov (Director of Emergency Medicine Research)
Maimonides Medical Center
Phone: 718-283-8693
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place