Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion
This study is currently recruiting participants.
Verified December 2011 by Ain Shams University
Sponsor:
Ain Shams University
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
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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
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, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013