An Evaluation of Oral Midazolam for Anxiety and Pain in First-trimester Surgical Abortion: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Subject Perception of Pain and Anxiety During Uterine Aspiration
研究概览
简要总结
The purpose of this study is to determine the level of pain, anxiety and side effects that women experience with a surgical abortion and the effect that the anti-anxiety medication, midazolam, might have when used along with ibuprofen and a paracervical block (PCB) instead of the standard pain treatment of only ibuprofen and a PCB.
详细描述
Women in the study will be randomized to receive either midazolam or placebo. Every participant will still receive the standard oral medications for pain (ibuprofen) as well as an injection of numbing medicine (lidocaine) near the cervix (PCB). The co-primary outcomes are patient perception of anxiety and pain with uterine aspiration reported on a 100 mm visual analogue scale (VAS). Secondary outcomes include reported anxiety and pain at time points before, during, and after the procedure, as well as subject satisfaction with anxiety and pain control and overall abortion experience. Due to the dose-dependent anterograde amnesic effect of midazolam, we will also investigate the effects on memory and recall, which has not previously been studied. In addition, we will also collect data on side effects frequently associated with oral midazolam such as nausea and sleepiness. Women will also be responsible for completing a one-page survey 1-3 days after the procedure visit and return it by mail using a pre-addressed and stamped envelope.
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
- Double (Participant, 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 between 6 0/7 and 10 6/7 weeks gestation, dated by ultrasound
- •Eligible for suction aspiration
- •English or Spanish speaking
- •Good general health
- •Able and willing to give informed consent and agree to terms of the study
- •Have assistance home; no driving for 24 hours
排除标准
- •- Gestational ages 11 0/7 weeks or more
- •Gestational age less than 6 0/7 weeks
- •Incomplete abortion
- •Premedication with misoprostol
- •Use of narcotic pain or anti-anxiety medication within past 24 hours
- •Use of heroin or methadone within last 3 months
- •Chronic alcoholism or alcohol intoxication within past 24 hours
- •Requested narcotics or Intravenous sedation (prior to randomization)
- •Allergic reaction or allergy to cherry/cherry flavoring or lidocaine or non-steroidal anti-inflammatory drugs (NSAIDs)
- •Allergic reaction or sensitivity to benzodiazepines including hyperactive or aggressive behavior (paradoxical reaction)
- •Medical problem necessitating inpatient procedure
- •Untreated acute cervicitis or pelvic inflammatory disease
- •Known acute narrow-angle glaucoma
- •Weighing less than 100 lb (45 kg)
- •Use of potent medications interfering with microsomal metabolism within past 48 hours (carbamazepine (Tegretol), cimetidine (Tagamet), diltiazem (Cardizem), erythromycin, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), phenobarbital, phenytoin (Dilantin), nelfinavir, ranitidine (Zantac), rifampin (Rifadin), ritonavir (Norvir), saquinavir, verapamil (Calan))
研究组 & 干预措施
placebo-cherry syrup and ibuprofen
5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
干预措施: Ibuprofen (Drug)
placebo-cherry syrup and ibuprofen
5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
干预措施: Placebo-Cherry syrup (Other)
placebo-cherry syrup and ibuprofen
5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
干预措施: Lidocaine (Drug)
Midazolam and ibuprofen
5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
干预措施: Midazolam (Drug)
Midazolam and ibuprofen
5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
干预措施: Ibuprofen (Drug)
Midazolam and ibuprofen
5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
干预措施: Lidocaine (Drug)
结局指标
主要结局
Subject Perception of Pain and Anxiety During Uterine Aspiration
时间窗: at time of uterine aspiration (30-60 minutes after premedication)
Subjects will be asked to rate anxiety and pain at the time of uterine aspiration by marking along a 100 mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety
次要结局
- Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline(Baseline (upon entry into study))
- State-Trait Anxiety Inventory for Anxiety at Baseline(Baseline (upon entry into study))
- Subject Extent of Amnesia Using Amnesia Score(30 minutes postoperatively)
- Subject Extent of Amnesia(1-3 days postoperatively)
- Subject Perception of Pain and Anxiety Post Procedure(30 minutes post operatively)
- Subject Vital Signs (Heart Rate)(intraoperatively (30-60 minutes after premedication))
- Subject Perception of Pain and Anxiety Upon Entering Procedure Room(upon entering procedure room (30-60 minutes after premedication))
- Subject Perception of Anxiety With Patient Positioning Procedure(prior to starting pelvic exam (30-60 minutes after premedication))
- Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure(1-3 days post-operatively)
- Subject Nausea 30 Minutes Postprocedure(30 minutes postoperatively)
- Subject Perception of Pain During Cervical Dilation(with cervical dilation (30-60 minutes after premedication))
- Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively(30 minutes post-operatively)
- Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure(30 minutes postoperatively)
- Subject's Correct Identification of Receiving Midazolam or Placebo(30 minutes postoperatively)
- Subject Vital Signs (Oxygenation Saturation)(intraoperatively (30-60 minutes after premedication))
- Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure(30 minutes postoperatively)
- Number of Participants With Need for Additional Postoperative Pain Medication(30 minutes postoperatively)
- Subject Extent of Sedation(30-60 minutes after premedication)
- Subject Sleepiness 30 Minutes Postprocedure(30 minutes postoperatively)
研究者
Lisa Bayer, MD MPH
MD
Oregon Health and Science University