NCT02332057

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

7 months

First QC Date

January 4, 2015

Last Update Submit

July 26, 2016

Conditions

Pain

Keywords

IUD,Diclofenac , Lidocaine

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain

    Pain intensity will be assessed by visual analogue scale during the procedure [an expected average of 3 minutes]

Secondary Outcomes (1)

  • Adverse effects of diclofenac and lidocaine

    Within 24 hours after IUD insertion

Study Arms (2)

Diclofenac plus lidocaine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Diclofenac plus lidocaineDRUG

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.

Diclofenac plus lidocaine
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of reproductive age requesting IUD for contraception

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics and Gynecology Department,Cairo university

Cairo, Egypt

Location

Related Publications (2)

  • McNicholas CP, Madden T, Zhao Q, Secura G, Allsworth JE, Peipert JF. Cervical lidocaine for IUD insertional pain: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):384.e1-6. doi: 10.1016/j.ajog.2012.09.018. Epub 2012 Sep 20.

    PMID: 23107081BACKGROUND

  • Fouda UM, Salah Eldin NM, Elsetohy KA, Tolba HA, Shaban MM, Sobh SM. Diclofenac plus lidocaine gel for pain relief during intrauterine device insertion. A randomized, double-blinded, placebo-controlled study. Contraception. 2016 Jun;93(6):513-8. doi: 10.1016/j.contraception.2016.02.001. Epub 2016 Feb 4.

    PMID: 26852833DERIVED

MeSH Terms

Conditions

Pain

Interventions

DiclofenacLidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Usama M Fouda, M.D,PhD

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, PhD

Study Record Dates

First Submitted

January 4, 2015

First Posted

January 6, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

EG(1)