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10% Lidocaine Spray for Intrauterine Device Insertion

NCT03870711 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2020-01-30

No results posted yet for this study

Summary

Intrauterine device (IUD) insertion is a procedure that can cause pain. Fear of pain during IUD insertion is a barrier to use of this method. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD.

Conditions

  • Contraception
  • Intrauterine Device

Interventions

DRUG

lidocaine spray

10% lidocaine spray 4 puffs

DRUG

Placebo

Sterile water 4 puffs

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Nalinee Panichyawat · Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-12-17
Completion
2019-12-17

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03870711 on ClinicalTrials.gov