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OpenTrials
Completed

NCT Number: NCT02658773

Lidocaine-prilocaine Cream on IUD Insertion Pain

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.

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lidocaine-prilocaine cream

Drug

placebo cream

Drug

Primary outcomes

  1. Mean pain score during IUD insertion

    Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Cervical Lidocaine-prilocaine Cream on IUD Insertion Pain: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 20, 2016
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.