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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499743
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Samy aly ashour, Cairo University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 20, 2018
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 5, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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Egypt
Obsterics and Gynecology Department
Cairo, Egypt, 11231
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: AHMED SAMY, MD Cairo University

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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: April 17, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celecoxib
Scopolamine
Bromides
Butylscopolammonium Bromide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Muscarinic Antagonists
Parasympatholytics