Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device
研究概览
简要总结
This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on pain scores during cervical dilator placement prior to dilation and evacuation (D&E).
详细描述
Potential participants will be first introduced to the study via routine intake call. Participants will be identified at the participant's office visits to the Johns Hopkins' Women's Center for Family Planning. If a patient desires D&E for a second trimester pregnancy, the patient will first receive standard counseling. Only after providing written informed consent for the procedure will the patients be screened for eligibility in the study. If the patient is eligible the participant will be asked by a member of the research team if the patient is interested in participating. If the patient is, the study will be explained to the participant and written consent will be obtained after participant is given the opportunity to have all questions answered.
The study is randomized, double-blind, placebo-controlled trial involving 2 arms. Participants will first complete a survey to collect demographic data.
Participants in both arms will receive the institution's current standard analgesia for cervical dilator placement. In addition to this standard regimen, participants will be randomized to receive either: (1) a dose of two oral placebo pills, or (2) 1mg of oral lorazepam with 5 mg of oral oxycodone prior to cervical dilator placement.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participant, provider, and nursing staff will be blinded to the intervention. The pharmacy will prepare the treatment drugs and placebos.. Randomization will be stratified by gestational age (>= 20 weeks or <20 weeks) and the randomization allocation sequence will be computer-generated with a random number generator by a statistician. The pharmacist will be aware of the randomization sequence and will dispense the drugs as appropriate, while keeping track of which arms participants were randomized to.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-50 years
- •English speaking
- •With an intrauterine pregnancy (either viable or non-viable) between the gestational ages of 17w0d and 23w6d
- •Have a support person present with participant
- •Have a cell phone capable of text messaging (optional)
排除标准
- •Non-English-speaking
- •Taking a daily benzodiazepine or opiate
- •Have a known allergy or contraindication to NSAIDs, opiates, or benzodiazepines
研究组 & 干预措施
Placebo Arm
Two oral placebo pills (microcrystalline cellulose capsules)
干预措施: Placebo Comparator (Drug)
Active Drug Arm: Lorazepam and Oxycodone
1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)
干预措施: Oxycodone and Lorazepam (Active Comparator) (Drug)
结局指标
主要结局
Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device
时间窗: Immediately after the last dilator is placed, up to 1 minute
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
次要结局
- Pain Score Before Speculum Placement(pain score given before specula placed, up to 1 minute)
- Baseline Pain Score Before Drugs Were Administered(pain score given prior to administration of study drugs, up to 1 minute)
- Pain Score After First Dilator Placement(pain score given immediately after first dilator placed, up to 1 minute)
- Pain Score at Tenaculum Placement(Immediately scored at time of tenacula placement, up to 1 minute)
- Pain Score 15 Minutes After Last Dilator Placed(Assessed up to 45 minutes after last dilator placed)
- Number of Participants With Desired Number of Dilators Inserted(After speculum removed, up to 30 minutes)
- Pain Score After Speculum Placement(pain score given at time of speculum placement, up to 1 minute)
- Pain Score During Paracervical Block(pain score given at time of paracervical block administration, up to 1 minute)