Diclofenac Plus Lidocaine Gel for Pain Relief During Intrauterine Device Insertion(IUD).

Cairo University (CU)

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Placebo; Drug: Diclofenac plus lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02332057

Diclofenac/lidocaine/IUD

Details and patient eligibility

About

The aim of this study is to determine the effectiveness of a combination of diclofenac and lidocaine gel in reducing pain during IUD insertion.

Full description

Various studies evaluating the use of local anesthetics or misoprostol prior to IUD insertion have mixed results.We think that the combination of diclofenac and lidocaine gel could be more successful in relieving pain during IUD insertion than single therapy.The aim of this study is to determine the effectiveness of a combination of diclofenac and lidocaine gel in reducing pain during IUD insertion.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of reproductive age requesting IUD for contraception

Exclusion criteria

• Patients with contraindications to IUD insertion ( less than 6 weeks postpartum, less than 2 weeks after abortion, uterine anomalies, fibroid distorting uterine cavity, pregnancy, pelvic inflammatory disease, cervicitis, uterine depth less than 6 cm or more than 9 cm) , previous IUD insertion, allergy to diclofenac or lidocaine, peptic ulcer , asthma, bleeding disorders, cardiac, liver or kidney diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Diclofenac plus lidocaine

Active Comparator group

Description:

Diclofenac(100 mg) is administered 1 hour before IUD insertion and lidocaine gel is placed on cervix three minutes before IUD insertion

Treatment:

Drug: Diclofenac plus lidocaine

Placebo

Placebo Comparator group

Description:

Placebo tablets is administered 1 hour before IUD insertion and placebo gel is placed on cervix three minutes before IUD insertion

Treatment:

Drug: Placebo