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Hydrocodone For Pain Control in First Trimester Surgical Abortion

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ClinicalTrials.gov Identifier: NCT01330459
Recruitment Status : Completed
First Posted : April 7, 2011
Results First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Planned Parenthood Federation of America
Information provided by (Responsible Party):
Elizabeth Micks, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Hydrocodone/acetaminophen Drug: Placebo Drug: Ibuprofen Drug: Lorazepam Drug: Lidocaine Phase 4

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of Hydrocodone/Acetaminophen for Pain Control in First Trimester Surgical Abortion
Study Start Date : February 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

Drug: Hydrocodone/acetaminophen
Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.
Other Name: Vicodin

Drug: Ibuprofen
800 mg oral ibuprofen

Drug: Lorazepam
2 mg oral lorazepam

Drug: Lidocaine
20 ml 1% buffered lidocaine, injected

Placebo Comparator: 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.

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

Drug: Ibuprofen
800 mg oral ibuprofen

Drug: Lorazepam
2 mg oral lorazepam

Drug: Lidocaine
20 ml 1% buffered lidocaine, injected




Primary Outcome Measures :
  1. Patient Perception of Pain [ Time Frame: At time of uterine aspiration (baseline) ]
    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.


Secondary Outcome Measures :
  1. Patient Perception of Pain During Cervical Dilation [ Time Frame: During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting) ]
    Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded after cervical dilation

  2. Satisfaction With Pain Control [ Time Frame: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration) ]
    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.

  3. Postoperative Nausea [ Time Frame: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration) ]
    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.

  4. Need for Additional Intraoperative and/or Postoperative Pain Medication [ Time Frame: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration) ]
    To assess need for additional intraoperative and/or postoperative pain medication



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330459


Locations
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United States, Oregon
Planned Parenthood CW
Portland, Oregon, United States, 97206
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Elizabeth Micks
Planned Parenthood Federation of America
Investigators
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Principal Investigator: Elizabeth Micks, MD Oregon Health and Science University

Additional Information:
Publications:
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.
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elizabeth Micks, Fellow in Family Planning, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01330459     History of Changes
Other Study ID Numbers: OHSU FAMPLAN 6734
First Posted: April 7, 2011    Key Record Dates
Results First Posted: April 26, 2019
Last Update Posted: April 26, 2019
Last Verified: April 2019

Keywords provided by Elizabeth Micks, Oregon Health and Science University:
Pain during first trimester surgical abortion

Additional relevant MeSH terms:
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Lidocaine
Lorazepam
Hydrocodone
Acetaminophen, hydrocodone drug combination
Oxycodone
Acetaminophen
Ibuprofen
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anticonvulsants
Antiemetics
Autonomic Agents
Gastrointestinal Agents