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

April 1, 2011
March 20, 2012
February 2011
October 2011   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01330459 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Hydrocodone For Pain Control in First Trimester Surgical Abortion
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.

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: Hydrocodone/acetaminophen
    Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.
    Other Name: Vicodin
  • Drug: Placebo
    Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.
  • Active Comparator: Hydrocodone/acetaminophen
    Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.
    Intervention: Drug: Hydrocodone/acetaminophen
  • Placebo Comparator: Placebo
    Subject will receive placebo 45-90 minutes prior to abortion procedure.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01330459
OHSU FAMPLAN 6734
No
Elizabeth Micks, Oregon Health & Science University
Elizabeth Micks
Planned Parenthood Federation of America
Principal Investigator: Elizabeth Micks, MD Oregon Health and Science University
Oregon Health and Science University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP