Hydrocodone For Pain Control in First Trimester Surgical Abortion

Elizabeth Micks121 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

121

Conditions

Pain

Interventions

Hydrocodone/acetaminophenDRUG

Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.

PlaceboDRUG

Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.

IbuprofenDRUG

800 mg oral ibuprofen

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Planned Parenthood CW

Portland, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Patient Perception of Pain

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.

Time frame: At time of uterine aspiration (baseline)

Secondary Outcomes

Patient Perception of Pain During Cervical Dilation

Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded after cervical dilation

Time frame: During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting)

Satisfaction With Pain Control

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.

Time frame: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

Postoperative Nausea

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.

Time frame: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

Need for Additional Intraoperative and/or Postoperative Pain Medication

To assess need for additional intraoperative and/or postoperative pain medication

Time frame: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

Data from ClinicalTrials.gov

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