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

Marina Ramsis Aziz Ghaly

Status: Enrolling

Conditions: Lidocaine Toxicity

Treatments: Diagnostic Test: The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05241496

AinShams univ

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 estimated patient

Sex: Female

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Marina Ramsis

Experimental group

Description:

In the other group, 70 women will be randomly assigned for ibuprofen; participants will take 1 tablet (400mg) immediately \& clinicians will wait at least 45 minutes before inserting the copper IUD

Treatment:

Diagnostic Test: The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration