Lidocaine-prilocaine Cream on IUD Insertion Pain
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|ClinicalTrials.gov Identifier: NCT02658773|
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : August 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|IUD Pain||Drug: lidocaine-Prilocaine cream Drug: placebo cream||Phase 2|
IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.
To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain. Many trials have been done about effectiveness of lidocaine gel in reducing pain during IUD insertion and only one of those trials showed positive effect of 2% lidocaine gel, while others failed.
Lidocaine 2.5% and Prilocaine 2.5% Cream, is an emulsion in which the oil phase is a eutectic mixture of Lidocaine and Prilocaine cream in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as liquid oil rather than as crystals. Its absorption of from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. After a 5 to 10 minute application of Lidocaine-Prilocaine cream to female genital mucosa, the average duration of effective analgesia was 15 to 20 minutes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Effect of Cervical Lidocaine-prilocaine Cream on IUD Insertion Pain: A Randomized Controlled Trial|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||June 2016|
Active Comparator: lidocaine-Prilocaine cream
lidocaine-Prilocaine anesthetic cream placed into their cervix prior to having the IUD inserted
Drug: lidocaine-Prilocaine cream
Placebo Comparator: placebo cream
an inert placebo cream placed into their cervix
Drug: placebo cream
- Mean pain score during IUD insertion [ Time Frame: 5 minutes ]
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): NCT02658773
|Assiut, Cairo, Egypt, 002|