Anesthetic Efficacy of Intrauterine Lidocaine for Removal of a "Lost" Intrauterine Device
| Tracking Information | |||||
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| First Received Date ICMJE | March 29, 2006 | ||||
| Last Updated Date | October 17, 2008 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00308841 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Anesthetic Efficacy of Intrauterine Lidocaine for Removal of a "Lost" Intrauterine Device | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | Objective: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during the removal of a "lost" intrauterine device (IUD). Methods: This double-blinded, randomized, placebo-controlled trial included 68 women who underwent removal procedure for a "lost" IUD. Thirty-four women were allocated to the lidocaine group and 34 to the saline group. The main outcome measure was the intensity of pain during, immediately after, and 20 minutes after the procedure, assessed by a visual analog scale. Statistical analysis was performed using Friedman's test with Bonferroni correction, Student's t test, and 2. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | "Lost" IUD | ||||
| Intervention ICMJE | Drug: Lidocaine (drug) | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Guney M, Oral B, Mungan T. Efficacy of intrauterine lidocaine for removal of a "lost" intrauterine device: a randomized, controlled trial. Obstet Gynecol. 2006 Jul;108(1):119-23. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: patients undergoing a minor gynecologic procedure for removal of a "lost" IUD. Exclusion Criteria: women with a history of cervical stenosis, known allergy to lidocaine, pregnancy, acute cervicitis |
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Turkey | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00308841 | ||||
| Other Study ID Numbers ICMJE | B.30.2.SDÜ.0.01.00.01.301.01 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Suleyman Demirel University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Suleyman Demirel University | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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