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Completed

NCT Number: NCT03499743

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

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.

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Key information

Conditions

IUD Insertion Pain

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obsterics and Gynecology Department

Cairo, 11231, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

hyoscine butyl bromide

Drug

intake of 10 mg hyoscine butyl bromide (buscopan) orally in addition to a placebo similar to Celecoxib 2 hours before IUD insertion

Celecoxib 200mg

Drug

Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to a placebo similar to hyoscine butyl bromide

Placebo oral tablet

Drug

a placebo similar to hyoscine butyl bromide in addition to a placebo similar to Celecoxib.

Primary outcomes

  1. self-reported pain score

    Time frame: 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 outcomes

  1. difference in pain score

    Time frame: 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.

  2. immediate complications related to IUD insertion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Celecoxib Versus Hyoscine Butyl-bromide in Reducing Pain Perception During Copper T380A Intrauterine Device Insertion: a Randomized Double-blind Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2018
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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