drugset / Trial / NCT01330459
Hydrocodone For Pain Control in First Trimester Surgical Abortion
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine whether preoperatively administered hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.
Timeline
- Start
- 2011-02
- Primary completion
- 2011-10
- Completion
- 2011-10
Publications
- Background 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. doi: 10.1016/j.contraception.2006.06.002. Epub 2006 Aug 2.
- Background Belanger E, Melzack R, Lauzon P. Pain of first-trimester abortion: a study of psychosocial and medical predictors. Pain. 1989 Mar;36(3):339-350. doi: 10.1016/0304-3959(89)90094-8.
- Background 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. doi: 10.1111/j.1365-2044.1988.tb05538.x.
- Background 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. doi: 10.1053/eujp.2000.0174.
- Background 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. doi: 10.1067/mob.2001.114858.
- Background 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. doi: 10.1097/01.AOG.0000127981.53911.0e.
- Background 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. doi: 10.1097/01.AOG.0000194204.71925.4a.
- Background 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. doi: 10.1111/j.1365-2044.1989.tb09206.x.
- Background 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. doi: 10.1016/s1526-5900(03)00716-8.
- Background 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. doi: 10.1016/j.contraception.2004.03.013.
- Background 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.
- Background 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. doi: 10.1016/j.contraception.2008.11.005. Epub 2008 Dec 11.
- Background Renner RM, Jensen JT, Nichols MD, Edelman A. Pain control in first trimester surgical abortion. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD006712. doi: 10.1002/14651858.CD006712.pub2.
- Background 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. doi: 10.1016/j.contraception.2007.09.008. Epub 2007 Nov 26.
- Background Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-132. doi: 10.1016/S0304-3959(01)00371-2. No abstract available.
- Background 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. doi: 10.1016/j.contraception.2008.03.011. Epub 2008 May 27.
- Background Suprapto K, Reed S. Naproxen sodium for pain relief in first-trimester abortion. Am J Obstet Gynecol. 1984 Dec 15;150(8):1000-1. doi: 10.1016/0002-9378(84)90399-5.
- Background 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. doi: 10.1016/s0196-0644(96)70238-x.
- Background Uppington, J. (2006). Opioids. In J. Ballantyne (Ed.), Massachusetts General Hospital Handbook of Pain Management (pp. 106-126). Philadelphia: Lippincott Williams & Wilkins.
- Background Safe Abortion: Technical and Policy Guidance for Health Systems. 2nd edition. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK138196/
- Background Wiebe E, Podhradsky L, Dijak V. The effect of lorazepam on pain and anxiety in abortion. Contraception. 2003 Mar;67(3):219-21. doi: 10.1016/s0010-7824(02)00516-4.
- Background Wiebe ER, Rawling M. Pain control in abortion. Int J Gynaecol Obstet. 1995 Jul;50(1):41-6. doi: 10.1016/0020-7292(95)02416-a.
- Micks EA, Edelman AB, Renner RM, Fu R, Lambert WE, Bednarek PH, Nichols MD, Beckley EH, Jensen JT. Hydrocodone-acetaminophen for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012 Nov;120(5):1060-9. doi: 10.1097/aog.0b013e31826c32f0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 650 mg | — |
| Comparator | Hydrocodone | Unknown | 10 mg | Oral |
| Comparator | Ibuprofen | Small molecule | 800 mg | Oral |
| Comparator | Lidocaine | Other / unclassified | 1 % | Other |
| Comparator | Lidocaine | Other / unclassified | 20 ml | Other |
| Comparator | Lorazepam | Small molecule | 2 mg | Oral |
Indications
No indication recorded.