Hydrocodone For Pain Control in First Trimester Surgical Abortion
Information source: Oregon Health and Science University
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Hydrocodone/acetaminophen (Drug); Placebo (Drug)
Phase: Phase 4
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
Rozie Janik, Phone: 503-494-0585, Email: email@example.com
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
Anticipated and reported pain at various time points
Satisfaction with pain control and overall abortion experience
Need for additional intraoperative and/or postoperative pain medication
Participants belief whether they received HC/APAP or placebo
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.
- Aged 18 years or older
- Voluntarily requesting surgical pregnancy termination
- Pregnancy with intrauterine gestational sac up to 10 weeks 6 days gestation, dated by
- 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
- 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 and Contacts
Rozie Janik, Phone: 503-494-0585, Email: firstname.lastname@example.org
Oregon Health & Science University, Portland, Oregon 97239, United States; Recruiting
Planned Parenthood CW, Portland, Oregon 97206, United States; Recruiting
Micromedex (2010). Hydrocodone bitartrate/acetaminophen
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.
Edelman A, Nichols MD, Leclair C, Jensen JT. Four percent intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol. 2006 Feb;107(2 Pt 1):269-75.
Heath PJ, Ogg TW. Prophylactic analgesia for daycase termination of pregnancy. A double-blind study with controlled release dihydrocodeine. Anaesthesia. 1989 Dec;44(12):991-4.
Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14.
Kan AS, Ng EH, Ho PC. The role and comparison of two techniques of paracervical block for pain relief during suction evacuation for first-trimester pregnancy termination. Contraception. 2004 Aug;70(2):159-63.
Nichols, M. D., Halvorson-Boyd, G., Goldstein, R., Gevirtz, C., & Healow, D. (2009). Pain management. In M. Paul, E. S. Lichtenberg, L. Borgatta, D. A. Grimes & P. G. Stubblefield (Eds.), Management of unintended and abnormal pregnancy. (pp. 90-110): Wiley-Blackwell.
O'Connell K, Jones HE, Simon M, Saporta V, Paul M, Lichtenberg ES; National Abortion Federation Members. First-trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception. 2009 May;79(5):385-92. Epub 2008 Dec 11.
Renner RM, Jensen JT, Nichols MD, Edelman A. Pain control in first trimester surgical abortion. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006712. Review.
Romero I, Turok D, Gilliam M. A randomized trial of tramadol versus ibuprofen as an adjunct to pain control during vacuum aspiration abortion. Contraception. 2008 Jan;77(1):56-9. Epub 2007 Nov 26.
Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-2. Review. No abstract available.
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.
Suprapto K, Reed S. Naproxen sodium for pain relief in first-trimester abortion. Am J Obstet Gynecol. 1984 Dec 15;150(8):1000-1.
Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9.
Wiebe E, Podhradsky L, Dijak V. The effect of lorazepam on pain and anxiety in abortion. Contraception. 2003 Mar;67(3):219-21.
Wiebe ER, Rawling M. Pain control in abortion. Int J Gynaecol Obstet. 1995 Jul;50(1):41-6.
Starting date: February 2011
Last updated: July 20, 2011