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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2023-10-10

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Lidocaine Toxicity

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Marina Ramsis

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

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

Lidocaine in spray form is a simple and convenient local anaesthetic with minimal adverse effects and is often used in dentistry for oral mucosal anaesthesia during minor surgical interventions. The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration. Lidocaine acts by stabilization of the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action (Hüseyin Aksoy et al. ,2016 ) .

Interventions

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

Lidocaine in spray form is a simple and convenient local anaesthetic with minimal adverse effects and is often used in dentistry for oral mucosal anaesthesia during minor surgical interventions. The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration. Lidocaine acts by stabilization of the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action (Hüseyin Aksoy et al. ,2016 ) .

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes