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

Cairo University (CU)

Status: Completed

Conditions: IUD Insertion Pain

Treatments: Drug: Celecoxib 200mg; Drug: Placebo Oral Tablet; Drug: hyoscine butyl bromide

Study type: Interventional

Funder types: Other

Identifiers

NCT03499743

IUD insertion pain

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups, including a placebo group

group1 (hyoscine Butyl-bromide group)

Experimental group

Description:

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.

Treatment:

Drug: hyoscine butyl bromide

group 3 (PLACEBO GROUP)

Placebo Comparator group

Description:

will receive a placebo similar to hyoscine butyl bromide in addition to a placebo similar to Celecoxib 2 hours before IUD insertion.

Treatment:

Drug: Placebo Oral Tablet

group 2(celecoxib group)

Experimental group

Description:

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.

Treatment:

Drug: Celecoxib 200mg