Trial Outcomes & Findings for Intrathecal Hydromorphone for Labor Analgesia (NCT NCT01598506)
NCT ID: NCT01598506
Last Updated: 2018-01-12
Results Overview
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
30 minutes after intrathecal injection
Results posted on
2018-01-12
Participant Flow
Subjects enrolled from January 2013 to November 2013
Participant milestones
| Measure |
Hydromorphone
Laboring patients receive ED50 of hydromorphone one time intrathecally.
ED50 of hydromorphone was 12.7 mcg +/- 3.27.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Hydromorphone
Laboring patients receive ED50 of hydromorphone one time intrathecally.
ED50 of hydromorphone was 12.7 mcg +/- 3.27.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Intrathecal Hydromorphone for Labor Analgesia
Baseline characteristics by cohort
| Measure |
Hydromorphone
n=22 Participants
Laboring patients receive ED50 of hydromorphone one time intrathecally.
ED50 of hydromorphone was 12.7 mcg +/- 3.27.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after intrathecal injectionContinuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Outcome measures
| Measure |
Hydromorphone
n=20 Participants
Laboring patients receive ED50 of hydromorphone one time intrathecally.
ED50 of hydromorphone was 10.9 (95% CI +/- 1.2 mcg).
|
|---|---|
|
Pain Score, Visual Analogue Pain Scores
|
1.9 units on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: BaselineContinuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Outcome measures
| Measure |
Hydromorphone
n=20 Participants
Laboring patients receive ED50 of hydromorphone one time intrathecally.
ED50 of hydromorphone was 10.9 (95% CI +/- 1.2 mcg).
|
|---|---|
|
Pain Scores, Visual Analogue Pain Scale
|
8.6 units on a scale
Interval 7.0 to 10.0
|
Adverse Events
Hydromorphone
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