Conditions: Pain
Keywords: Pain during first trimester surgical abortion
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 121
Healthy volunteers: no

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.

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).

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Hydrocodone/acetaminophen intervention 2: Placebo intervention 3: Ibuprofen intervention 4: Lorazepam intervention 5: Lidocaine
Intervention descriptions: intervention 1: Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure. intervention 2: Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure. intervention 3: 800 mg oral ibuprofen intervention 4: 2 mg oral lorazepam intervention 5: 20 ml 1% buffered lidocaine, injected

Protocol document: