Celecoxib Versus Hyoscine Butyl-bromide in Reducing Pain Perception During Copper T380A Intrauterine Device Insertion: a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- self-reported pain score
研究概览
简要总结
Many oral analgesic drugs such as the nonsteroidal anti-inflammatory drug (NSAID) are used to relieve pain from gynaecological procedures and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug is commonly used for relief of smooth muscle spasms and can be used to alleviate genito-urinary spasm. Some studies reported hyoscine couldn't relieve pain in minor gynaecological procedures. So the efficacy of Hyoscine-N-butyl bromide use is still controversial, and no previous studies investigated its effectiveness for pain relief in IUD insertion procedure.
详细描述
The study objective is to compare the effectiveness and side effects of oral Celecoxib 200mg versus oral hyoscine butyl bromide 10 mg in reducing pain associated with IUD insertion. the study is an attempt to find the most effective drug with the least possible side effects to be used before IUD insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigators who will insert the IUDs and will collect important data, the patients and the statistician who will perform the final data analysis will be blinded to the group allocations
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Non-pregnant nulliparous and parous menstruating women.
- •Women who Did not receive any analgesics or misoprostol in the 24 hours prior to insertion.
- •Presenting for insertion of CuT380A intrauterine device.
- •the absence of contraindication for IUD insertion including positive cultures for gonorrhoea or chlamydia
- •the absence of sedative or long-acting narcotics use 48 h before IUD insertion
- •No history of severe mental stress in the past two months.
排除标准
- •• Allergy to HYOSCINE BUTYLBROMIDE or celecoxib or contraindication to it as paralytic ileus, myasthenia gravis, pyloric stenosis and narrow-angle glaucoma.
- •Women who had been pregnant within the previous four weeks.
- •Women presenting for IUD removal and reinsertion
- •Any uterine abnormalities distorted uterine cavity as congenital anomalies, endometrial lesions, adenomyosis, and submucous myoma.
- •Enrollment in another study.
- •A psychological or neurological disorder associated with altered pain sensation.
- •a history of dysmenorrhea
- •a contraindication for IUD use such as a gynaecological malignancy, pelvic inflammatory disease or undiagnosed abnormal vaginal bleeding.
研究组 & 干预措施
group1 (hyoscine Butyl-bromide group)
group1 will receive hyoscine butyl bromide 10 mg (BUSCOPAN tablets, produced by Chemical Industries Development (CID), Giza - A.R.E. under licence of Boehringer Ingelheim International GmbH - Germany) orally in addition to a placebo similar to Celecoxib 2 hours before IUD insertion.
干预措施: hyoscine butyl bromide (Drug)
group 3 (PLACEBO GROUP)
will receive a placebo similar to hyoscine butyl bromide in addition to a placebo similar to Celecoxib 2 hours before IUD insertion.
干预措施: Placebo Oral Tablet (Drug)
group 2(celecoxib group)
group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to a placebo similar to hyoscine butyl bromide 2 hours before IUD insertion.
干预措施: Celecoxib 200mg (Drug)
结局指标
主要结局
self-reported pain score
时间窗: during IUD insertion
the visual analog scale (VAS ) pain score reported by participants during IUD insertion.Pain scores will be measured using a visual analogue scale (VAS) consisting of a 10 cm horizontal straight line on which 0 cm corresponds to no pain and 10 cm to the worst pain. VAS is rated as 0 for no pain, 1-3 for mild pain, 4-6 for average pain, and 7-9 for severe pain and 10 for extremely severe pain an individual can experience.A research assistant standing beside the woman will hold the VAS sheet for the participant to select the point that corresponds to the level of pain she will experience.
次要结局
- difference in pain score(during tenaculum placement, during sound insertion, and 5 minutes after IUD insertion.)
- immediate complications related to IUD insertion(30 minutes after insertion)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University