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Study of Pain Control With Hormonal IUS Insertion

NCT02352714 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2018-09-14

No results posted yet for this study

Summary

This study aims to compare pain during insertion of the Skyla® IUS using a 100mm visual analog scale (VAS) among 92 young women aged 14 to 22 years randomized to receive a paracervical (n=46) block versus a sham paracervical block (n=46).

Conditions

Interventions

DRUG

Paracervical Nerve Block

Block randomization to receive lidocaine paracervical nerve block vs sham cervical block

DRUG

Sham Paracervical Block

Block randomization to receive lidocaine paracervical nerve block vs sham cervical block

Sponsors & Collaborators

Principal Investigators

  • Aletha Y Akers, MD, MPH · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
22 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02352714 on ClinicalTrials.gov