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Completed

NCT Number: NCT01330459

Hydrocodone For Pain Control in First Trimester Surgical Abortion

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science University, Portland, Oregon, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocodone/Acetaminophen

Drug

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

Other names: Vicodin

Placebo

Drug

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

Ibuprofen

Drug

800 mg oral ibuprofen

Lorazepam

Drug

2 mg oral lorazepam

Lidocaine

Drug

20 ml 1% buffered lidocaine, injected

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Elizabeth Micks

Other

Collaborators

  • Planned Parenthood Federation of America

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 7, 2011
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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