An Evaluation of Hydrocodone/Acetaminophen for Pain Control in First Trimester Surgical Abortion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Patient Perception of Pain
研究概览
简要总结
The purpose of this study is to determine whether preoperatively administered hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Ibuprofen (Drug)
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.
干预措施: Lidocaine (Drug)
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.
干预措施: Hydrocodone/acetaminophen (Drug)
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.
干预措施: Lorazepam (Drug)
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.
干预措施: Lidocaine (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: Ibuprofen (Drug)
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.
干预措施: Lorazepam (Drug)
结局指标
主要结局
Patient Perception of Pain
时间窗: 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.
次要结局
- Patient Perception of Pain During Cervical Dilation(During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting))
- Satisfaction With Pain Control(30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration))
- Postoperative Nausea(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(30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration))
研究者
Elizabeth Micks
Fellow in Family Planning
Oregon Health and Science University