Trial Outcomes & Findings for Prevention of Narcotic-Induced Nausea (NCT NCT00541671)
NCT ID: NCT00541671
Last Updated: 2014-03-13
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
4 hours post opiate administration
Results posted on
2014-03-13
Participant Flow
Participant milestones
| Measure |
Placebo
Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
|
Promethazine
Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Narcotic-Induced Nausea
Baseline characteristics by cohort
| Measure |
Placebo
n=13 Participants
Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
|
Promethazine
n=12 Participants
Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Greater than or equal to 18
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Sex/Gender, Customized
|
NA participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hours post opiate administrationOutcome measures
| Measure |
Placebo
n=12 Participants
Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
|
Promethazine
n=13 Participants
Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
|
|---|---|---|
|
Number of Patients Who Became Nauseated After IV Opiate Administration.
|
5 participants
|
4 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Promethazine
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