Lidocaine Spray 10% Versus Oral Ibuprofen Tablets in Pain Control During Copper Intrauterine Device Insertion

  • STATUS
    Recruiting
  • End date
    Oct 10, 2023
  • participants needed
    1
  • sponsor
    Marina Ramsis Aziz Ghaly
Updated on 4 October 2022
Accepts healthy volunteers

Summary

The intrauterine contraceptive device (IUD) is the most commonly used form of reversible contraception worldwide; the predominant type of product, the copper IUD (a plastic T-shaped device with copper affixed to it) was developed over 30 years ago and has become the standard bearer for intrauterine contraception, due to its long-term effectiveness, safety and affordability .

Inconsistent use and discontinuation of contraceptives are major causes of unintended pregnancy . The failure rate of the patch or ring is 20 times higher than that of long acting reversible contraceptives (LARCs) . Increasing acceptability and use of LARC methods like the intrauterine device (IUD) is an important strategy to reduce the risk of unintended pregnancy

Description

The aim of this study is to This study is designed to compare between lidocaine spray 10% and oral ibuprofen as an adequate method for decreasing pain during copper intrauterine contraceptive device insertion .

Research question:

Which of both drugs ( local lidocaine spray 10% or oral ibuprofen tab.) is more effective in decreasing pain during IUD insertion ? Research Hypothesis In this current study, we hypothesize that using of local cervical lidocaine spray 10% prior to IUD insertion will decrease the pain more effectively than ibuprofen tablet 400 mg.

Details
Condition Lidocaine Toxicity
Treatment The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration
Clinical Study IdentifierNCT05241496
SponsorMarina Ramsis Aziz Ghaly
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Multiparous women in 3rd to 5th day of menstrual cycle 2- Women who were 6 weeks
postpartum or if recently pregnant. 3- Accept to participate and provide consent

Exclusion Criteria

• A contraindication for IUD use such as a gynecological malignancy , sexually
transmitted diseases, pelvic inflammatory disease or undiagnosed abnormal vaginal
bleeding
Suspicion of pregnancy
Allergy to lidocaine or ibuprofen
Copper allergy
Any uterine abnormalities distorted uterine cavity as congenital anomalies
endometrial lesions, adenomyosis , and submucous myoma
A psychological or neurological disorder associated with altered pain sensation
MIRENA insertion
Nulliparity
History of failed intrauterine device insertion (uterine perforation, acute
expulsion)
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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