Hydrocodone For Pain Control in First Trimester Surgical Abortion

NCT01330459 | Completed Phase 4 Results

• 1 other identifier: OHSU FAMPLAN 6734
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pain

Keywords

Pain during first trimester surgical abortion

Outcome Measures

Primary Outcomes (1)

• 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.

  At time of uterine aspiration (baseline)

Secondary Outcomes (4)

• Patient Perception of Pain During Cervical Dilation

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

• Satisfaction With Pain Control

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

• Postoperative Nausea

  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

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

Study Arms (2)

Hydrocodone/acetaminophen

ACTIVE COMPARATOR

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.

Drug: Hydrocodone/acetaminophen; Drug: Ibuprofen; Drug: Lorazepam; Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Ibuprofen; Drug: Lorazepam; Drug: Lidocaine

Interventions

Hydrocodone/acetaminophen DRUG

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

Also known as: Vicodin

Hydrocodone/acetaminophen

Placebo DRUG

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

Placebo

Ibuprofen DRUG

800 mg oral ibuprofen

Hydrocodone/acetaminophen; Placebo

Lorazepam DRUG

2 mg oral lorazepam

Hydrocodone/acetaminophen; Placebo

Lidocaine DRUG

20 ml 1% buffered lidocaine, injected

Hydrocodone/acetaminophen; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elizabeth Micks: lead
• Planned Parenthood Federation of America: collaborator

Study Sites (2)

Planned Parenthood CW

Portland, Oregon, 97206, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (23)

• 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.

  PMID: 17046383 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.

  PMID: 2710563 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.

  PMID: 3364636 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.

  PMID: 10957701 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.

  PMID: 11408881 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.

  PMID: 15172863 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.

  PMID: 16449111 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.

  PMID: 2619027 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.

  PMID: 14622683 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.

  PMID: 15288222 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.

  PMID: 19341852 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.

  PMID: 19370649 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.

  PMID: 18082668 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.

  PMID: 11690725 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.

  PMID: 18672118 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.

  PMID: 6507524 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.

  PMID: 8604867 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/

  PMID: 23700650 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.

  PMID: 12618257 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.

  PMID: 7556858 BACKGROUND

• 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.

  PMID: 23090523 DERIVED

MeSH Terms

Conditions

Pain

Interventions

oxycodone-acetaminophen; acetaminophen, hydrocodone drug combination; Ibuprofen; Lorazepam; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Alison Edelman, MD, Assistant Professor
• Organization: Oregon Health and Science University

edelmana@ohsu.edu

(503) 494-3666

Study Officials

• Elizabeth Micks, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fellow in Family Planning

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 7, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 26, 2019
• Results First Posted: April 26, 2019

Record last verified: 2019-04

Locations

US (2)