Hydrocodone For Pain Control in First Trimester Surgical Abortion

Elizabeth Micks

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Placebo; Drug: Hydrocodone/acetaminophen; Drug: Lorazepam; Drug: Lidocaine; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT01330459

OHSU FAMPLAN 6734

Details and patient eligibility

About

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

Full 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).

Enrollment: 121 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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121 participants in 2 patient groups, including a placebo group

Hydrocodone/acetaminophen

Active Comparator group

Description:

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.

Treatment:

Drug: Lorazepam

Drug: Ibuprofen

Drug: Lidocaine

Drug: Hydrocodone/acetaminophen

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Lorazepam

Drug: Placebo

Drug: Ibuprofen

Drug: Lidocaine