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

Last updated: July 18, 2022
Sponsor: Marina Ramsis Aziz Ghaly
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05241496
AinShams univ
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • • A contraindication for IUD use such as a gynecological malignancy , sexuallytransmitted diseases, pelvic inflammatory disease or undiagnosed abnormal vaginalbleeding.
  • 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, acuteexpulsion).

Study Design

Total Participants: 1
Study Start date:
December 15, 2021
Estimated Completion Date:
October 10, 2023

Study 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.

Connect with a study center

  • AinSHAMS UNIV

    Cairo, 11531
    Egypt

    Active - Recruiting

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