Hydrocodone For Pain Control in First Trimester Surgical Abortion

• 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).
  
  

• 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
  
  

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).