Trial Outcomes & Findings for Hydrocodone For Pain Control in First Trimester Surgical Abortion (NCT NCT01330459)

Results Overview

To determine whether HC/APAP, given in addition to a standard regimen of ibuprofen, lorazepam, and PCB, affects patient pain perception at the time of uterine aspiration, as measured by distance (mm) from the left of the 100 mm visual analog scale (VAS). The number 0 indicates no pain, and 100 indicates worst pain imaginable.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

121 participants

Primary outcome timeframe

At time of uterine aspiration (baseline)

Results posted on

2019-04-26

Participant Flow

Subjects in this study are women 18 years or older, recruited from OHSU and PPCW who present for an elective termination of pregnancy up to 10 weeks 6 days gestation

Participant milestones

Participant milestones
Measure	Hydrocodone/Acetaminophen Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.	Placebo Subject will receive placebo 45-90 minutes prior to abortion procedure.
Overall Study STARTED	61	60
Overall Study COMPLETED	61	58
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Hydrocodone/Acetaminophen Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.	Placebo Subject will receive placebo 45-90 minutes prior to abortion procedure.
Overall Study Physician Decision	0	2

Baseline Characteristics

Hydrocodone For Pain Control in First Trimester Surgical Abortion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydrocodone/Acetaminophen n=61 Participants Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.	Placebo n=60 Participants Subject will receive placebo 45-90 minutes prior to abortion procedure.	Total n=121 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants	58 Participants n=7 Participants	118 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.1 years STANDARD_DEVIATION 6.3 • n=5 Participants	24.7 years STANDARD_DEVIATION 4.5 • n=7 Participants	25.4 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	60 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants	60 participants n=7 Participants	121 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of uterine aspiration (baseline)

To determine whether HC/APAP, given in addition to a standard regimen of ibuprofen, lorazepam, and PCB, affects patient pain perception at the time of uterine aspiration, as measured by distance (mm) from the left of the 100 mm visual analog scale (VAS). The number 0 indicates no pain, and 100 indicates worst pain imaginable.

Outcome measures

Outcome measures
Measure	Hydrocodone/Acetaminophen n=61 Participants Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.	Placebo n=58 Participants Subject will receive placebo 45-90 minutes prior to abortion procedure.
Patient Perception of Pain	65.7 mm Standard Deviation 25.4	63.1 mm Standard Deviation 26.6

SECONDARY outcome

Timeframe: During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting)

Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded after cervical dilation

Outcome measures

Outcome measures
Measure	Hydrocodone/Acetaminophen n=59 Participants Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.	Placebo n=58 Participants Subject will receive placebo 45-90 minutes prior to abortion procedure.
Patient Perception of Pain During Cervical Dilation	47.2 mm Standard Deviation 26.8	43.9 mm Standard Deviation 28.9

SECONDARY outcome

Timeframe: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

Distance (mm) from the left of the 100 mm VAS (VAS anchors: 0 = unsatisfied, 100 mm = very satisfied) recorded 30 minutes after completion of the procedure.

Outcome measures

Outcome measures
Measure	Hydrocodone/Acetaminophen n=61 Participants Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.	Placebo n=60 Participants Subject will receive placebo 45-90 minutes prior to abortion procedure.
Satisfaction With Pain Control	74.8 mm Standard Deviation 24.7	67.3 mm Standard Deviation 24.7

SECONDARY outcome

Timeframe: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

To assess whether HC/APAP is associated with nausea, measured on the 100 mm VAS, recorded 30 minutes postoperatively. VAS anchors: 0 indicates no pain, and 100 indicates worst pain imaginable.

Outcome measures

Outcome measures
Measure	Hydrocodone/Acetaminophen n=60 Participants Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.	Placebo n=58 Participants Subject will receive placebo 45-90 minutes prior to abortion procedure.
Postoperative Nausea	19.4 mm Standard Deviation 27.0	11.4 mm Standard Deviation 21.5

SECONDARY outcome

Timeframe: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

To assess need for additional intraoperative and/or postoperative pain medication

Outcome measures

Outcome measures
Measure	Hydrocodone/Acetaminophen n=61 Participants Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.	Placebo n=60 Participants Subject will receive placebo 45-90 minutes prior to abortion procedure.
Need for Additional Intraoperative and/or Postoperative Pain Medication	0 Participants	0 Participants

Adverse Events

Hydrocodone/Acetaminophen

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Hydrocodone/Acetaminophen n=61 participants at risk Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.	Placebo n=60 participants at risk Subject will receive placebo 45-90 minutes prior to abortion procedure.
Reproductive system and breast disorders Uterine perforation	0.00% 0/61	1.7% 1/60 • Number of events 1
Reproductive system and breast disorders Hematometra requiring reaspiration	1.6% 1/61 • Number of events 1	0.00% 0/60

Other adverse events

Other adverse events
Measure	Hydrocodone/Acetaminophen n=61 participants at risk Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.	Placebo n=60 participants at risk Subject will receive placebo 45-90 minutes prior to abortion procedure.
Gastrointestinal disorders Vomiting	3.3% 2/61 • Number of events 2	1.7% 1/60 • Number of events 1

Additional Information

Alison Edelman, MD, Assistant Professor

Oregon Health and Science University

Phone: (503) 494-3666

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place