Hydrocodone For Pain Control in First Trimester Surgical Abortion

Condition(s) targeted: Pain

Intervention: Hydrocodone/acetaminophen (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Oregon Health and Science University

Official(s) and/or principal investigator(s):
Elizabeth Micks, MD, Principal Investigator, Affiliation: Oregon Health and Science University

Overall contact:
Rozie Janik, Phone: 503-494-0585, Email: janik@ohsu.edu

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

Official title: An Evaluation of Hydrocodone/Acetaminophen for Pain Control in First Trimester Surgical Abortion

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Patient Perception of Pain

Secondary outcome:

Anticipated and reported pain at various time points

Baseline Anxiety

Satisfaction with pain control and overall abortion experience

Side effects

Adverse Events

Need for additional intraoperative and/or postoperative pain medication

Participants belief whether they received HC/APAP or placebo

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Rozie Janik, Phone: 503-494-0585, Email: janik@ohsu.edu

Oregon Health & Science University, Portland, Oregon 97239, United States; Recruiting

Planned Parenthood CW, Portland, Oregon 97206, United States; Recruiting

Micromedex (2010). Hydrocodone bitartrate/acetaminophen

Related publications:

Allen RH, Kumar D, Fitzmaurice G, Lifford KL, Goldberg AB. Pain management of first-trimester surgical abortion: effects of selection of local anesthesia with and without lorazepam or intravenous sedation. Contraception. 2006 Nov;74(5):407-13. Epub 2006 Aug 2.

Bélanger E, Melzack R, Lauzon P. Pain of first-trimester abortion: a study of psychosocial and medical predictors. Pain. 1989 Mar;36(3):339-50.

Bone ME, Dowson S, Smith G. A comparison of nalbuphine with fentanyl for postoperative pain relief following termination of pregnancy under day care anaesthesia. Anaesthesia. 1988 Mar;43(3):194-7.

Dahl V, Fjellanger F, Raeder JC. No effect of preoperative paracetamol and codeine suppositories for pain after termination of pregnancies in general anaesthesia. Eur J Pain. 2000;4(2):211-5.

Edelman A, Nichols MD, Jensen J. Comparison of pain and time of procedures with two first-trimester abortion techniques performed by residents and faculty. Am J Obstet Gynecol. 2001 Jun;184(7):1564-7.

Edelman A, Nichols MD, Leclair C, Astley S, Shy K, Jensen JT. Intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol. 2004 Jun;103(6):1267-72.

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Singh RH, Ghanem KG, Burke AE, Nichols MD, Rogers K, Blumenthal PD. Predictors and perception of pain in women undergoing first trimester surgical abortion. Contraception. 2008 Aug;78(2):155-61. Epub 2008 May 27.

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Starting date: February 2011
Last updated: July 20, 2011