Hydrocodone For Pain Control in First Trimester Surgical Abortion

April 3, 2019 updated by: Elizabeth Micks

An Evaluation of Hydrocodone/Acetaminophen for Pain Control in First Trimester Surgical Abortion

The purpose of this study is to determine whether preoperatively administered hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators plan to conduct a double-blinded randomized placebo-controlled trial of 120 women undergoing elective first trimester surgical abortion. These women will be premedicated with either two tabs of 5/350 hydrocodone/acetaminophen or 2 tabs of a placebo. All subjects will receive ibuprofen and lorazepam preoperatively and a PCB. This study will examine the incremental benefit of HC/APAP over this standard medication regimen. Randomization will be stratified into two groups. Subjects less than 8 weeks gestation will comprise the early gestational age group. Subjects between 8 weeks 0 days and 10 weeks 6 days will comprise the late gestational age group. The investigators will be assessing patient perception of pain, nausea, satisfaction, and anxiety at multiple points during the clinic visit using 100-mm visual analogue scales (VAS).

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97206
        • Planned Parenthood CW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Aged 18 years or older
  • Voluntarily requesting surgical pregnancy termination
  • Pregnancy with intrauterine gestational sac up to 10 weeks 6 days gestation, dated by ultrasound
  • Eligible for suction curettage
  • English or Spanish speaking
  • Good general health
  • Able and willing to give informed consent and agree to terms of the study

Exclusion Criteria:

  • Gestational ages 11 weeks or more
  • Incomplete abortion
  • Premedication with misoprostol
  • Use of any opioid medication within the past 7 days
  • Use of heroin within the past 7 days
  • Requested opioids or IV sedation prior to start of the procedure
  • Patients who refuse ibuprofen or lorazepam
  • Contraindications or allergies to HC/APAP, lidocaine, ibuprofen, or lorazepam
  • Significant medical problem necessitating inpatient procedure
  • Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
  • Known hepatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hydrocodone/acetaminophen

Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.

Subject will also recieve ibuprofen, lorazepam, and lidocaine 45-90 minutes prior to abortion procedure.
Drug: Hydrocodone/acetaminophen
Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.
Other Names:
  • Vicodin
Drug: Ibuprofen
800 mg oral ibuprofen
Drug: Lorazepam
2 mg oral lorazepam
Drug: Lidocaine
20 ml 1% buffered lidocaine, injected
PLACEBO_COMPARATOR: Placebo

Subject will receive placebo 45-90 minutes prior to abortion procedure.

Subject will also recieve ibuprofen, lorazepam, and lidocaine 45-90 minutes prior to abortion procedure.
Drug: Ibuprofen
800 mg oral ibuprofen
Drug: Lorazepam
2 mg oral lorazepam
Drug: Lidocaine
20 ml 1% buffered lidocaine, injected
Drug: Placebo
Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Perception of Pain
Time Frame: 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.
At time of uterine aspiration (baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Perception of Pain During Cervical Dilation
Time Frame: 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
During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting)
Satisfaction With Pain Control
Time Frame: 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.
30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)
Postoperative Nausea
Time Frame: 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.
30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)
Need for Additional Intraoperative and/or Postoperative Pain Medication
Time Frame: 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
30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elizabeth Micks

Collaborators

Planned Parenthood Federation of America

Investigators

  • Principal Investigator: Elizabeth Micks, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (ESTIMATE)

April 7, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHSU FAMPLAN 6734

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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