Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pain during contrast infiltration
研究概览
简要总结
Hysterosalpingogram (HSG) testing is a vital part of the workup for infertility patients. It is often noted to be biggest pain that patients undergo during the workup. Several studies have attempted to find a therapy that reduces pain, with non-steroidal anti-inflammatory drugs such as oral ibuprofen the current mainstay. Our study attempts to determine which of the following NSAIDS is best at reducing pain associated with the HSG procedure: oral ibuprofen versus oral ketorolac .
详细描述
Describe step-by-step how the study will be conducted from beginning to end
- After IRB approval, the research pharmacist will provide motrin and ketorolac in identical packets labeled 1-88, after receiving the randomization strategy/number set from the research monitor.
- REI physician on the protocol will screen patient for inclusion/exclusion from study at new patient consult or at future follow up visit when need for HSG is decided.
- If patient pt screens eligible, discuss study. If elects participation then consent patient and randomize to group.
- At time of scheduling HSG, patient will need to remind nursing that they are in HSG study. Nursing should also have the list of patients to reference when scheduling HSGs. Patients in the study will need to check in at the REI clinic 70 minutes prior to HSG in order to take their meds 60 minutes prior to scheduled procedure time. At same visit, REI RN will perform urine pregnancy test as previously scheduled.
a. meds will be kept in a locked cabinet in the REI research office in opaque sealed envelopes. 5. Patient will then go check into Radiology for their HSG. 6. HSG will be performed per standard clinical protocol. The HSG will be performed by REI physicians and OB/GYN residents (who are rotating on REI), which are the current standard of practice. 7. A nurse or provider associated with the study will need to be at the HSG for the sole purpose of study assistance. The provider performing the HSG, the study personnel recording pain levels, and the fluro tech will not be aware of the type of pre-procedural medication the patient received. The nurse or provider of study personnel will do the following:
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time the procedure from placement of speculum through deflation of catheter balloon and removal of catheter. Record time in seconds (can write mins:seconds and then convert later).
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record who performed the procedure, if a tenaculum had to be used, and if an attending had to take over the procedure
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help patient record pain scale marks on the VAS sheet at the designated time periods.
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For clarity- there will be at least three providers at each HSG for study enrolled patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Research pharmacist has provided either 800mg ibuprofen or 30mg ketorolac into oral capsules, and randomized sets of pills in packages 1-88. Research physicians and patients blinded which pill sets contain which drug. Will be revealed after data collection complete.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •premenopausal females age 18-45
- •patients currently undergoing HSG as part of routine work-up for infertility or subfertility, - - patients with negative urine pregnancy test within 24 hours of the scheduled procedure
- •patients having performance of HCG between menstrual cycle days 5-12n
排除标准
- •Non-English speaking
- •patients with history of previous HSG performed
- •patients with contrast allergy or other contraindications to HSG
- •patients with contraindications to NSAID use
- •Patients with the following:
- •unwilling to consent
- •positive urine pregnancy test within 24 hours of the scheduled procedure
- •active renal or hepatic disease
- •chronic narcotic users
- •use of pain medications within 12 hours of the scheduled procedure
- •patients with chronic pain conditions (fibromyalgia, complex regional pain syndrome, etc.)
- •patients with unknown uterine anatomical pathology
研究组 & 干预措施
Ibuprofen
Patients randomized to this arm will receive an identical capsule to the other patient arm, and receive 800mg ibuprofen 1 hour before HSG.
干预措施: Ibuprofen 800 mg oral (Drug)
Ketorolac
Patients randomized to this arm will receive an identical capsule to the other patient arm, and receive 30mg ketorolac 1 hour before HSG.
干预措施: Ketorolac 30mg oral (Drug)
结局指标
主要结局
Pain during contrast infiltration
时间窗: Between 0 seconds and 5 minutes
Pain on Visual Analogue Scale (0-100)
次要结局
- Pain with HSG catheter placement(Between 0 seconds and 5 minutes)
- Pain at baseline (before procedure start)(Between 0 seconds and 5 minutes)
- Pain at completion of HSG(Between 0 seconds and 5 minutes)
- Pain 5 minutes following HSG(5 minutes after procedure)