SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03499743

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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

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.

NCT03499743 IUD Insertion Pain

3 Interventions

Name: hyoscine butyl bromide

Description: intake of 10 mg hyoscine butyl bromide (buscopan) orally in addition to a placebo similar to Celecoxib 2 hours before IUD insertion

Type: Drug

group1 (hyoscine Butyl-bromide group)

Name: Celecoxib 200mg

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

Type: Drug

group 2(celecoxib group)

Name: Placebo Oral Tablet

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

Type: Drug

group 3 (PLACEBO GROUP)


Primary Outcomes

Description: 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.

Measure: self-reported pain score

Time: during IUD insertion

Secondary Outcomes

Description: 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.

Measure: difference in pain score

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

Description: 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.

Measure: immediate complications related to IUD insertion

Time: 30 minutes after insertion

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T380A

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



HPO Nodes