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Hydrocodone For Pain Control in First Trimester Surgical Abortion

Sponsor
Elizabeth Micks (Other)
Overall Status
Completed
CT.gov ID
NCT01330459
Collaborator
Planned Parenthood Federation of America (Other)
121
Enrollment
2
Locations
2
Arms
8
Duration (Months)
60.5
Patients Per Site
7.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
An Evaluation of Hydrocodone/Acetaminophen for Pain Control in First Trimester Surgical Abortion
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

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: Placebo
    Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.

    Drug: Ibuprofen
    800 mg oral ibuprofen

    Drug: Lorazepam
    2 mg oral lorazepam

    Drug: Lidocaine
    20 ml 1% buffered lidocaine, injected

    Outcome Measures

    Primary Outcome Measures

    1. Patient Perception of Pain [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.

    Secondary Outcome Measures

    1. Patient Perception of Pain During Cervical Dilation [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

    2. Satisfaction With Pain Control [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.

    3. Postoperative Nausea [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.

    4. 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)]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Planned Parenthood CW Portland Oregon United States 97206
    2 Oregon Health & Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Elizabeth Micks
    • Planned Parenthood Federation of America

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Elizabeth Micks, Fellow in Family Planning, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT01330459
    Other Study ID Numbers:
    • OHSU FAMPLAN 6734
    First Posted:
    Apr 7, 2011
    Last Update Posted:
    Apr 26, 2019
    Last Verified:
    Apr 1, 2019
    Keywords provided by Elizabeth Micks, Fellow in Family Planning, Oregon Health and Science University
    Pain during first trimester surgical abortion
    Additional relevant MeSH terms:
    Acetaminophen
    Ibuprofen
    Acetaminophen, hydrocodone drug combination
    Lidocaine
    Hydrocodone
    Lorazepam

    Study Results

    Participant Flow

    Recruitment Details 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
    Pre-assignment Detail
    Arm/Group Title Hydrocodone/Acetaminophen Placebo
    Arm/Group Description Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure. Subject will receive placebo 45-90 minutes prior to abortion procedure.
    Period Title: Overall Study
    STARTED 61 60
    COMPLETED 61 58
    NOT COMPLETED 0 2

    Baseline Characteristics

    Arm/Group Title Hydrocodone/Acetaminophen Placebo Total
    Arm/Group Description Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure. Subject will receive placebo 45-90 minutes prior to abortion procedure. Total of all reporting groups
    Overall Participants 61 60 121
    Age (Count of Participants)
    <=18 years
    1
    1.6%
    2
    3.3%
    3
    2.5%
    Between 18 and 65 years
    60
    98.4%
    58
    96.7%
    118
    97.5%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    26.1
    (6.3)
    24.7
    (4.5)
    25.4
    (5.5)
    Sex: Female, Male (Count of Participants)
    Female
    61
    100%
    60
    100%
    121
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    61
    100%
    60
    100%
    121
    100%

    Outcome Measures

    1. Primary Outcome
    Title Patient Perception of Pain
    Description 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.
    Time Frame At time of uterine aspiration (baseline)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Hydrocodone/Acetaminophen Placebo
    Arm/Group Description Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure. Subject will receive placebo 45-90 minutes prior to abortion procedure.
    Measure Participants 61 58
    Mean (Standard Deviation) [mm]
    65.7
    (25.4)
    63.1
    (26.6)
    2. Secondary Outcome
    Title Patient Perception of Pain During Cervical Dilation
    Description Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded after cervical dilation
    Time Frame During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Hydrocodone/Acetaminophen Placebo
    Arm/Group Description Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure. Subject will receive placebo 45-90 minutes prior to abortion procedure.
    Measure Participants 59 58
    Mean (Standard Deviation) [mm]
    47.2
    (26.8)
    43.9
    (28.9)
    3. Secondary Outcome
    Title Satisfaction With Pain Control
    Description 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.
    Time Frame 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Hydrocodone/Acetaminophen Placebo
    Arm/Group Description Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure. Subject will receive placebo 45-90 minutes prior to abortion procedure.
    Measure Participants 61 60
    Mean (Standard Deviation) [mm]
    74.8
    (24.7)
    67.3
    (24.7)
    4. Secondary Outcome
    Title Postoperative Nausea
    Description 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.
    Time Frame 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Hydrocodone/Acetaminophen Placebo
    Arm/Group Description Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure. Subject will receive placebo 45-90 minutes prior to abortion procedure.
    Measure Participants 60 58
    Mean (Standard Deviation) [mm]
    19.4
    (27.0)
    11.4
    (21.5)
    5. Secondary Outcome
    Title Need for Additional Intraoperative and/or Postoperative Pain Medication
    Description To assess 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)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Hydrocodone/Acetaminophen Placebo
    Arm/Group Description 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. Hydrocodone/acetaminophen: Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure. Ibuprofen: 800 mg oral ibuprofen Lorazepam: 2 mg oral lorazepam Lidocaine: 20 ml 1% buffered lidocaine, injected 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. Placebo: Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure. Ibuprofen: 800 mg oral ibuprofen Lorazepam: 2 mg oral lorazepam Lidocaine: 20 ml 1% buffered lidocaine, injected
    Measure Participants 61 60
    Count of Participants [Participants]
    0
    0%
    0
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Hydrocodone/Acetaminophen Placebo
    Arm/Group Description Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure. Subject will receive placebo 45-90 minutes prior to abortion procedure.
    All Cause Mortality
    Hydrocodone/Acetaminophen Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Hydrocodone/Acetaminophen Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/61 (1.6%) 1/60 (1.7%)
    Reproductive system and breast disorders
    Uterine perforation 0/61 (0%) 0 1/60 (1.7%) 1
    Hematometra requiring reaspiration 1/61 (1.6%) 1 0/60 (0%) 0
    Other (Not Including Serious) Adverse Events
    Hydrocodone/Acetaminophen Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/61 (3.3%) 1/60 (1.7%)
    Gastrointestinal disorders
    Vomiting 2/61 (3.3%) 2 1/60 (1.7%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Alison Edelman, MD, Assistant Professor
    Organization Oregon Health and Science University
    Phone (503) 494-3666
    Email edelmana@ohsu.edu
    Responsible Party:
    Elizabeth Micks, Fellow in Family Planning, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT01330459
    Other Study ID Numbers:
    • OHSU FAMPLAN 6734
    First Posted:
    Apr 7, 2011
    Last Update Posted:
    Apr 26, 2019
    Last Verified:
    Apr 1, 2019