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Trial record 9 of 456 for:    DICLOFENAC

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

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ClinicalTrials.gov Identifier: NCT02332057
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Usama M Fouda, Cairo University

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

Condition or disease Intervention/treatment Phase
Pain Drug: Diclofenac plus lidocaine Drug: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Diclofenac Plus Lidocaine Gel for Pain Relief During Intrauterine Device (IUD) Insertion. A Randomized Double Blinded Placebo-controlled Study
Study Start Date : February 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Diclofenac plus lidocaine
Diclofenac(100 mg) is administered 1 hour before IUD insertion and lidocaine gel is placed on cervix three minutes before IUD insertion
Drug: Diclofenac plus lidocaine
The study nurse will instruct the patients to swallow diclofenac tablets (100 mg) 1 hour before IUD insertion. Three millilitres of the lidocaine gel will be placed on the anterior lip of the cervix . A cotton swab socked in 3 ml of the lidocaine gel will be introduced in the cervical canal till the level of internal os. The cotton swab will be left in place for three minutes. The IUD will be inserted by experienced gynecologists according to the recommendations of manufacture.

Placebo Comparator: Placebo
Placebo tablets is administered 1 hour before IUD insertion and placebo gel is placed on cervix three minutes before IUD insertion
Drug: Placebo
The study nurse will instruct the patients to swallow placebo tablets 1 hour before IUD insertion. Three millilitres of the placebo gel will be placed on the anterior lip of the cervix . A cotton swab socked in 3 ml of the placebo gel will be introduced in the cervical canal till the level of internal os. The cotton swab will be left in place for three minutes. The IUD will be inserted by experienced gynecologists according to the recommendations of manufacture.




Primary Outcome Measures :
  1. Intensity of pain [ Time Frame: Pain intensity will be assessed by visual analogue scale during the procedure [an expected average of 3 minutes] ]

Secondary Outcome Measures :
  1. Adverse effects of diclofenac and lidocaine [ Time Frame: Within 24 hours after IUD insertion ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332057


Locations
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Egypt
Obstetrics and Gynecology Department,Cairo university
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Usama M Fouda, M.D,PhD Cairo University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Usama M Fouda, M.D, PhD, Cairo University
ClinicalTrials.gov Identifier: NCT02332057     History of Changes
Other Study ID Numbers: Diclofenac/lidocaine/IUD
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Keywords provided by Usama M Fouda, Cairo University:
IUD,Diclofenac , Lidocaine
Additional relevant MeSH terms:
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Diclofenac
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors