Hydrocodone For Pain Control in First Trimester Surgical Abortion

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330459
• Other study ID #: OHSU FAMPLAN 6734
• Status: Completed
• Phase: Phase 4
• Start date: February 2011
• Est. completion date: October 2011

Study information

• Verified date: April 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon
United States	Planned Parenthood CW	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Micks	Planned Parenthood Federation of America

Country where clinical trial is conducted

United States, 

References & Publications (22)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Renner RM, Jensen JT, Nichols MD, Edelman A. Pain control in first trimester surgical abortion. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006712. doi: 10.1002/14651858.CD006712.pub2. Review. — View Citation

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. — View Citation

Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-2. Review. — View Citation

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. — View Citation

Suprapto K, Reed S. Naproxen sodium for pain relief in first-trimester abortion. Am J Obstet Gynecol. 1984 Dec 15;150(8):1000-1. — View Citation

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. — View Citation

Uppington, J. (2006). Opioids. In J. Ballantyne (Ed.), Massachusetts General Hospital Handbook of Pain Management (pp. 106-126). Philadelphia: Lippincott Williams & Wilkins.

WHO (2003). Safe abortion:Technical and policy guidance for health systems

Wiebe E, Podhradsky L, Dijak V. The effect of lorazepam on pain and anxiety in abortion. Contraception. 2003 Mar;67(3):219-21. — View Citation

Wiebe ER, Rawling M. Pain control in abortion. Int J Gynaecol Obstet. 1995 Jul;50(1):41-6. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Perception of Pain During Cervical Dilation	Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded after cervical dilation	During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting)
Secondary	Satisfaction With Pain Control	Distance (mm) from the left of the 100 mm VAS (VAS anchors: 0 = unsatisfied, 100 mm = very satisfied) recorded 30 minutes after completion of the procedure.	30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)
Secondary	Postoperative Nausea	To assess whether HC/APAP is associated with nausea, measured on the 100 mm VAS, recorded 30 minutes postoperatively. VAS anchors: 0 indicates no pain, and 100 indicates worst pain imaginable.	30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)
Secondary	Need for Additional Intraoperative and/or Postoperative Pain Medication	To assess 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)

External Links

•   Micromedex (2010). Hydrocodone bitartrate/acetaminophen