Celecoxib Versus Hyoscine Butyl-bromide in Reducing Pain Associated With IUD.
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|ClinicalTrials.gov Identifier: NCT03499743|
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|IUD Insertion Pain||Drug: hyoscine butyl bromide Drug: Celecoxib 200mg Drug: Placebo Oral Tablet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|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|
|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 :||April 20, 2018|
|Actual Primary Completion Date :||September 1, 2018|
|Actual Study Completion Date :||September 5, 2018|
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
- self-reported pain score [ Time Frame: 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.
- difference in pain score [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499743
|Obsterics and Gynecology Department|
|Cairo, Egypt, 11231|
|Principal Investigator:||AHMED SAMY, MD||Cairo University|