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

NCT03499743 | Completed

• 1 other identifier: IUD insertion pain
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

IUD Insertion Pain

Outcome Measures

Primary Outcomes (1)

• self-reported pain score

  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.

  during IUD insertion

Secondary Outcomes (2)

• difference in pain score

  during tenaculum placement, during sound insertion, and 5 minutes after IUD insertion.

• immediate complications related to IUD insertion

  30 minutes after insertion

Study Arms (3)

group1 (hyoscine Butyl-bromide group)

EXPERIMENTAL

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.

Drug: hyoscine butyl bromide

group 3 (PLACEBO GROUP)

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

group 2(celecoxib group)

EXPERIMENTAL

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.

Drug: Celecoxib 200mg

Interventions

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

group1 (hyoscine Butyl-bromide group)

Celecoxib 200mg DRUG

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

group 2(celecoxib group)

Placebo Oral Tablet DRUG

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

group 3 (PLACEBO GROUP)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Obsterics and Gynecology Department

Cairo, 11231, Egypt

Location

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• AHMED SAMY, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators who will insert the IUDs and will collect important data, the patients and the statistician who will perform the final data analysis will be blinded to the group allocations
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: April 20, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 5, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

EG (1)