Hydrocodone For Pain Control in First Trimester Surgical Abortion
NCT ID: NCT01330459
Last Updated: 2019-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
121 participants
INTERVENTIONAL
2011-02-28
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Hydrocodone/acetaminophen
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.
Hydrocodone/acetaminophen
Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.
Ibuprofen
800 mg oral ibuprofen
Lorazepam
2 mg oral lorazepam
Lidocaine
20 ml 1% buffered lidocaine, injected
Placebo
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.
Placebo
Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.
Ibuprofen
800 mg oral ibuprofen
Lorazepam
2 mg oral lorazepam
Lidocaine
20 ml 1% buffered lidocaine, injected
Interventions
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Hydrocodone/acetaminophen
Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.
Placebo
Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.
Ibuprofen
800 mg oral ibuprofen
Lorazepam
2 mg oral lorazepam
Lidocaine
20 ml 1% buffered lidocaine, injected
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Planned Parenthood Federation of America
OTHER
Elizabeth Micks
OTHER
Responsible Party
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Elizabeth Micks
Fellow in Family Planning
Principal Investigators
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Elizabeth Micks, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Planned Parenthood CW
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. doi: 10.1016/j.contraception.2008.11.005. 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;2009(2):CD006712. doi: 10.1002/14651858.CD006712.pub2.
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.
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.
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.
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.
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.
Uppington, J. (2006). Opioids. In J. Ballantyne (Ed.), Massachusetts General Hospital Handbook of Pain Management (pp. 106-126). Philadelphia: Lippincott Williams & Wilkins.
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/
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.
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.
Other Identifiers
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OHSU FAMPLAN 6734
Identifier Type: -
Identifier Source: org_study_id
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