Celecoxib Versus Hyoscine Butyl-bromide in Reducing Pain Associated With IUD.

Not Applicable

Completed

• Conditions: IUD Insertion Pain
• Interventions: Drug: hyoscine butyl bromide; Drug: Placebo Oral Tablet; Drug: Celecoxib 200mg

• Registration Number: NCT03499743
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-17
• Study Start: 2018-04-20
• Status Verified: 2018-09
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-05
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

• 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.

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Exclusion Criteria

• • 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group1 (hyoscine Butyl-bromide group)	hyoscine butyl bromide	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.
group 3 (PLACEBO GROUP)	Placebo Oral Tablet	will receive a placebo similar to hyoscine butyl bromide in addition to a placebo similar to Celecoxib 2 hours before IUD insertion.
group 2(celecoxib group)	Celecoxib 200mg	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.

Primary Outcome Measures

Name	Time	Method
self-reported pain score	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.

Secondary Outcome Measures

Name	Time	Method
difference in pain score	during tenaculum placement, during sound insertion, and 5 minutes after IUD insertion.	the pain score at other different points; during tenaculum placement, during sound insertion, and 5 minutes after the end of insertion with a different sheet of paper at every point.
immediate complications related to IUD insertion	30 minutes after insertion	the immediate complications related to IUD insertion such as uterine perforation, failure of insertion, vasovagal reaction and bleeding and the number of women who will need analgesics after insertion.

Trial Locations

Locations (1)

Obsterics and Gynecology Department; 🇪🇬 Cairo, Egypt