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

NCT ID: NCT03499743

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2018-09-05

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.

Conditions

IUD Insertion Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

hyoscine butyl bromide

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Celecoxib 200mg

Intervention Type: DRUG

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

Interventions

hyoscine butyl bromide

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

Intervention Type: DRUG

Celecoxib 200mg

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

Intervention Type: DRUG

Placebo Oral Tablet

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samy aly ashour

lecturer in obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED SAMY, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Obsterics and Gynecology Department

Cairo, , Egypt

Countries

Egypt

Other Identifiers

IUD insertion pain

Identifier Type: -

Identifier Source: org_study_id