Clinical trial NCT03499743: Celecoxib Versus Hyoscine Butyl-bromide in Reducing Pain Associated With IUD.
Official title: Celecoxib Versus Hyoscine Butyl-bromide in Reducing Pain Perception During Copper T380A Intrauterine Device Insertion: a Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD Insertion Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: self-reported pain score
timeFrame: during IUD insertion
Secondary outcomes:
measure: difference in pain score
timeFrame: during tenaculum placement, during sound insertion, and 5 minutes after IUD insertion.
measure: immediate complications related to IUD insertion
timeFrame: 30 minutes after insertion
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Obsterics and Gynecology Department
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References: