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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
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Study Description
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Brief Summary:
The purpose of the investigators' study was to evaluate whether cervical lidocaine-Prilocaine cream will improve pain scores compared to placebo. The investigators hypothesized that lidocaine-Prilocaine cream will reduce the insertion pain.

Condition or disease Intervention/treatment Phase
IUD Pain Drug: lidocaine-Prilocaine cream Drug: placebo cream Phase 2

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
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

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Mean pain score during IUD insertion [ Time Frame: 5 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women not taken analgesics or anxiolytics in the 24 hours prior insertion
  • Women not taken misoprostol prior to IUD insertion
  • No contraindication to or history of allergic reaction to lidocaine
  • Women who will accept to participate in the study

Exclusion Criteria:

  • Lidocaine allergy
  • Any contraindication to IUD placement
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Egypt
Ahmed Abbas
Assiut, Cairo, Egypt, 002
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Ahmed Mohamed Abbas, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02658773    
Other Study ID Numbers: LPIUD
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Lidocaine
Prilocaine
Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined