Trial Outcomes & Findings for Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients? (NCT NCT03262038)
NCT ID: NCT03262038
Last Updated: 2021-01-19
Results Overview
number of participants with any incidence of pruritus
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
24 hours
Results posted on
2021-01-19
Participant Flow
Participant milestones
| Measure |
Ondansetron IV
Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)
Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.
|
Placebo
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
28
|
|
Overall Study
COMPLETED
|
18
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Ondansetron IV
Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)
Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.
|
Placebo
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ondansetron IV
n=18 Participants
Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)
Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.
|
Placebo
n=27 Participants
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
8.3 years
n=18 Participants
|
8.2 years
n=27 Participants
|
8.3 years
n=45 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=18 Participants
|
17 Participants
n=27 Participants
|
29 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=18 Participants
|
10 Participants
n=27 Participants
|
16 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
30.4 kg
n=18 Participants
|
34.0 kg
n=27 Participants
|
32.5 kg
n=45 Participants
|
|
ASA 1, 2
|
15 Participants
n=18 Participants
|
27 Participants
n=27 Participants
|
42 Participants
n=45 Participants
|
|
Surgical Service
Urology
|
14 Participants
n=18 Participants
|
22 Participants
n=27 Participants
|
36 Participants
n=45 Participants
|
|
Surgical Service
Orthopedics
|
4 Participants
n=18 Participants
|
5 Participants
n=27 Participants
|
9 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: 24 hoursnumber of participants with any incidence of pruritus
Outcome measures
| Measure |
Ondansetron IV
n=18 Participants
Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)
Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.
|
Placebo
n=27 Participants
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
|
|---|---|---|
|
Incidence of Pruritus
|
14 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Excludes those without any itch
number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)
Outcome measures
| Measure |
Ondansetron IV
n=14 Participants
Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)
Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.
|
Placebo
n=24 Participants
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
|
|---|---|---|
|
Severity of Pruritus
Mild / no treatment needed
|
1 Participants
|
4 Participants
|
|
Severity of Pruritus
Severe / requiring treatment
|
13 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 24 hoursnumber of participants with any incidence of postoperative nausea or vomiting
Outcome measures
| Measure |
Ondansetron IV
n=18 Participants
Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)
Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.
|
Placebo
n=27 Participants
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
|
|---|---|---|
|
Incidence of Post Operative Nausea or Vomiting
|
8 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: excludes those without any nausea vomiting
number of participants who Indicated mild post operative nausea or vomiting (no treatment needed) or severe postoperative nausea or vomiting(treatment needed)
Outcome measures
| Measure |
Ondansetron IV
n=8 Participants
Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)
Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.
|
Placebo
n=23 Participants
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
|
|---|---|---|
|
Severity of Post Operative Nausea or Vomiting
Mild / no treatment required
|
2 Participants
|
4 Participants
|
|
Severity of Post Operative Nausea or Vomiting
Severe / requiring treatment
|
6 Participants
|
19 Participants
|
Adverse Events
Ondansetron IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place