Hydrocodone For Pain Control in First Trimester Surgical Abortion

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Hydrocodone/acetaminophen
* Drug: Placebo
* Drug: Ibuprofen
* Drug: Lorazepam
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydrocodone/acetaminophen<br>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<br>* Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.<br>* Other names: Vicodin;Drug: Ibuprofen<br>* 800 mg oral ibuprofen<br>Drug: Lorazepam<br>* 2 mg oral lorazepam<br>Drug: Lidocaine<br>* 20 ml 1% buffered lidocaine, injected<br>|
| Placebo Comparator: Placebo<br>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<br>* Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.<br>Drug: Ibuprofen<br>* 800 mg oral ibuprofen<br>Drug: Lorazepam<br>* 2 mg oral lorazepam<br>Drug: Lidocaine<br>* 20 ml 1% buffered lidocaine, injected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain during first trimester surgical abortion