Glyceryl Trinitrate Versus Lidocaine Cream for IUD Insertion (GTN-IUD)

Topical Glyceryl Trinitrate Versus Lidocaine Cream as Analgesia for IUD Insertion: A Randomized Controlled Trial

The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive method that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method.

Study Overview

• Status: Completed
• Conditions: IUD Insertion
• Intervention / Treatment: Drug: placebo cream; Drug: glyceryl trinitrate cream; Drug: lidocaine cream

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

1. Women not taken analgesics or anxiolytics in the 24 hours prior insertion
2. Women not taken misoprostol prior to IUD insertion
3. No contraindication to or history of allergic reaction to lidocaine or NO donors.
4. Women who will accept to participate in the study

Exclusion criteria:

1. Lidocaine allergy
2. History of migraine or chronic headache
3. Any contraindication to IUD placement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: glyceryl trinitrate cream; The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine. 1 mL glyceryl trinitrate cream will be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab.	Drug: glyceryl trinitrate cream
EXPERIMENTAL: lidocaine cream; The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine. 1 mL lidocaine creamwill be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab.	Drug: lidocaine cream
PLACEBO_COMPARATOR: placebo cream; The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine.1 mL placebo cream will be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab.	Drug: placebo cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean pain score during IUD insertion	3 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient satisfaction score after the procedure	3 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Abbas AM, Ragab E, Abd Ellah NH, Sabra A, Ali SS, Mohamed A, Yosef AH. Effect of topical glyceryl trinitrate cream on pain perception during intrauterine device insertion in multiparous women: A randomized double-blinded placebo-controlled study. J Gynecol Obstet Hum Reprod. 2019 Nov;48(9):715-718. doi: 10.1016/j.jogoh.2019.03.007. Epub 2019 Mar 18.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (ESTIMATE): March 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Nitroglycerin
• Other Study ID Numbers: GTN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES