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Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Ain Shams University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mohamed Saied Eldin Elsafty, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01496105
First received: December 13, 2011
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to determine whether the topical use of lidocaine spray 10% on the cervix is an effective way to reduce pain during IUCD insertion.


Condition Intervention Phase
Drug Usage
Drug: Lidocaine
Drug: saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • VAS score of Pain [ Time Frame: 5 minutes from lidocaine spraying ( after application of tenaculum) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lidocaine spray 10% Drug: Lidocaine
Placebo Comparator: Saline Drug: saline

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-45
  • Speak Arabic or English

Exclusion Criteria:

  • History of cervical surgery
  • Known hypersensitivity to topical analgesics
  • First trimester abortion or miscarriage in the previous six weeks
  • Second trimester abortion or miscarriage in the previous 12 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496105

Contacts
Contact: Mohamed S.Eldin Elsafty, Lecturer +201003922211 emeira2@gmail.com

Locations
Egypt
Ain shams university hospital Recruiting
Cairo, Egypt
Contact: Mohamed Ibrahim Emeira, Lecturer    +201224456471    emeira2@gmail.com   
Sponsors and Collaborators
Ain Shams University
  More Information

No publications provided

Responsible Party: Mohamed Saied Eldin Elsafty, Lecturer of Obstetrics and Gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT01496105     History of Changes
Other Study ID Numbers: ali elyan 2011
Study First Received: December 13, 2011
Last Updated: December 20, 2011
Health Authority: Egypt: Ministry of Health and Population

Additional relevant MeSH terms:
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 19, 2014