Clinical trial NCT01330459: Hydrocodone For Pain Control in First Trimester Surgical Abortion
Official title: An Evaluation of Hydrocodone/Acetaminophen for Pain Control in First Trimester Surgical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Pain during first trimester surgical abortion
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Planned Parenthood Federation of America
First posted: 2011-04-07
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: Patient Perception of Pain
timeFrame: At time of uterine aspiration (baseline)
Secondary outcomes:
measure: Patient Perception of Pain During Cervical Dilation
timeFrame: During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting)
measure: Satisfaction With Pain Control
timeFrame: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)
measure: Postoperative Nausea
timeFrame: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)
measure: Need for Additional Intraoperative and/or Postoperative Pain Medication
timeFrame: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Planned Parenthood CW
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Elizabeth Micks, MD
role: PRINCIPAL_INVESTIGATOR
References:
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