Hydrocodone For Pain Control in First Trimester Surgical Abortion

Phase 4

Completed

Conditions: Pain

Interventions: Drug: Placebo
Drug: Hydrocodone/acetaminophen
Drug: Ibuprofen
Drug: Lorazepam
Drug: Lidocaine

Registration Number: NCT01330459

Lead Sponsor: Elizabeth Micks

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 121

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocodone/acetaminophen	Lidocaine	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.
Placebo	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.
Hydrocodone/acetaminophen	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.
Hydrocodone/acetaminophen	Lorazepam	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.
Placebo	Ibuprofen	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	Lorazepam	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.
Hydrocodone/acetaminophen	Ibuprofen	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.
Placebo	Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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.
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