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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03499743

Collaborator

(none)

105

Enrollment

Location

Arms

4.5

Actual Duration (Months)

23.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IUD Insertion Pain	Drug: hyoscine butyl bromide Drug: Celecoxib 200mg Drug: Placebo Oral Tablet	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 20, 2018

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Sep 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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
Placebo Comparator: 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.	Drug: Placebo Oral Tablet a placebo similar to hyoscine butyl bromide in addition to a placebo similar to Celecoxib.
Experimental: 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.	Drug: Celecoxib 200mg Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to a placebo similar to hyoscine butyl bromide

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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

Placebo Comparator: 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.

Drug: Placebo Oral Tablet

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

Experimental: 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.

Drug: Celecoxib 200mg

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

Outcome Measures

Primary Outcome Measures

self-reported pain score [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 Outcome Measures

difference in pain score [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.
immediate complications related to IUD insertion [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obsterics and Gynecology Department	Cairo		Egypt	11231

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: AHMED SAMY, MD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Samy aly ashour, lecturer in obstetrics and gynecology, Cairo University

ClinicalTrials.gov Identifier:

NCT03499743

Other Study ID Numbers:

IUD insertion pain

First Posted:

Apr 17, 2018

Last Update Posted:

Sep 7, 2018

Last Verified:

Sep 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Celecoxib

Scopolamine

Bromides

Butylscopolammonium Bromide

Study Results

No Results Posted as of Sep 7, 2018