Trial Outcomes & Findings for Hydromorphone and C-section (NCT NCT01598545)

Results Overview

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

12 hours after intrathecal injection

Results posted on

2014-12-17

Participant Flow

Subjects enrolled from January 2013 to June 2014 at Grady Memorial Hospital.

Participant milestones

Participant milestones
Measure	Hydromorphone Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief. ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hydromorphone and C-section

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydromorphone n=20 Participants Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief. ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours after intrathecal injection

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

Outcome measures

Outcome measures
Measure	Hydromorphone n=20 Participants Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief. ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg.
Pain Scores, Visual Analogue Pain Scale	2.75 units on a scale Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: Baseline

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

Outcome measures

Outcome measures
Measure	Hydromorphone n=20 Participants Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief. ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg.
Pain Scores, Visual Analogue Pain Scale	0.45 units on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 6 hours after intrathecal injection

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

Outcome measures

Outcome measures
Measure	Hydromorphone n=20 Participants Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief. ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg.
Pain Scores, Visual Analogue Pain Scale	4.4 units on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 18 hours after intrathecal injection

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

Outcome measures

Outcome measures
Measure	Hydromorphone n=20 Participants Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief. ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg.
Pain Scores, Visual Analogue Pain Scale	3.05 units on a scale Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: 24 hours after intrathecal injection

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

Outcome measures

Outcome measures
Measure	Hydromorphone n=20 Participants Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief. ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg.
Pain Scores, Visual Analogue Pain Scale	3.3 units on a scale Interval 0.0 to 7.0

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

Dr. Grant Lynde

Emory University

Phone: 404-778-3900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place