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Nitrous Oxide for Pain Management During IUD Insertion in Nulliparous Adolescent Women

NCT04089852 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2022-09-16

No results posted yet for this study

Summary

This pilot study aims to assess the feasibility, acceptability, and effectiveness of using nitrous oxide (N2O) sedation for intrauterine device (IUD) insertions for nulliparous adolescent and young adult women in a primary care clinic setting.

Conditions

  • Contraceptive Devices
  • Long-Acting Reversible Contraception
  • Analgesia
  • Adolescent Health
  • Gynecology

Interventions

DRUG

Nitrous oxide gas for inhalation

All inhaled gases will be administered via nasal mask using a portable nitrous oxide/oxygen (N2O/O2) machine. Environmental safety will be maintained with an N2O scavenger system and Porter Miniature Vacuum System. The treatment group will receive inhaled N2O/O2. The N2O will be gradually up-titrated to a goal ratio of 70/30 N2O/O2 and will be administered as outlined in the treatment arm description.

DRUG

Oxygen Gas for Inhalation

All inhaled gases will be administered via nasal mask using a portable nitrous oxide/oxygen (N2O/O2) machine. The control group will receive inhaled O2 alone. Control group participants will receive 100% O2 for two minutes prior to speculum placement. Inhaled oxygen will be administered continuously throughout the procedure as outlined in the control arm description.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-11-01
Completion
2021-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT04089852 on ClinicalTrials.gov