Hydrocodone For Pain Control in First Trimester Surgical Abortion

This study has been completed.
Sponsor:
Collaborator:
Planned Parenthood Federation of America
Information provided by (Responsible Party):
Elizabeth Micks, Oregon Health & Science University
ClinicalTrials.gov Identifier:
NCT01330459
First received: April 1, 2011
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Pain
Drug: Hydrocodone/acetaminophen
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of Hydrocodone/Acetaminophen for Pain Control in First Trimester Surgical Abortion

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Patient Perception of Pain [ Time Frame: At time of uterine aspiration (baseline) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Anticipated and reported pain at various time points [ Time Frame: One Year ] [ Designated as safety issue: No ]

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

    • prior to premedication
    • after receiving premedication, just prior to procedure
    • after speculum insertion
    • with placement of the PCB
    • with cervical dilation
    • 30 minutes postoperatively
    • intrapersonal pain changes (calculated in analysis)

  • Baseline Anxiety [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded prior to premedication.

  • Satisfaction with pain control and overall abortion experience [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    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.

  • Side effects [ Time Frame: One Year ] [ Designated as safety issue: No ]

    To assess whether HC/APAP is associated with the following side effects: nausea, pruritis and sleepiness using VAS Scales (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded:

    • prior to premedication
    • 30 minutes postoperatively

  • Adverse Events [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

    To determine whether the effect of HC/APAP is associated with the following adverse events: allergic reaction, postabortal syndrome, need for uterine reaspiration, excessive blood loss, excessive sedation; recorded:

    • Preoperatively
    • intraoperatively
    • 30 minutes postoperatively

  • Need for additional intraoperative and/or postoperative pain medication [ Time Frame: One Year ] [ Designated as safety issue: No ]
    To assess need for additional intraoperative and/or postoperative pain medication

  • Participants belief whether they received HC/APAP or placebo [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Participants belief whether they received HC/APAP or placebo recorded 30 minutes postoperatively


Enrollment: 122
Study Start Date: February 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hydrocodone/acetaminophen
Subject will receive hydrocodone/acetaminophen 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 Name: Vicodin
Placebo Comparator: Placebo
Subject will receive placebo 45-90 minutes prior to abortion procedure.
Drug: Placebo
Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330459

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Planned Parenthood CW
Portland, Oregon, United States, 97206
Sponsors and Collaborators
Elizabeth Micks
Planned Parenthood Federation of America
Investigators
Principal Investigator: Elizabeth Micks, MD Oregon Health and Science University
  More Information

Publications:
Nichols, M. D., Halvorson-Boyd, G., Goldstein, R., Gevirtz, C., & Healow, D. (2009). Pain management. In M. Paul, E. S. Lichtenberg, L. Borgatta, D. A. Grimes & P. G. Stubblefield (Eds.), Management of unintended and abnormal pregnancy. (pp. 90-110): Wiley-Blackwell.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elizabeth Micks, Fellow in Family Planning, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT01330459     History of Changes
Other Study ID Numbers: OHSU FAMPLAN 6734
Study First Received: April 1, 2011
Last Updated: March 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Pain during first trimester surgical abortion

Additional relevant MeSH terms:
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014