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Use of Nitrous Oxide for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Dilatation and Evacuation

NCT05579288 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-10-13

No results posted yet for this study

Summary

A randomised control study aiming to examine whether inhaled N2O/O2 during cervical preparation for second trimester dilatation and evacuation with osmotic dilators (laminaria) alleviates pain and is superior to placebo.

Conditions

  • Pain Alleviation
  • Dilatation and Evacuation
  • Laminaria Placement
  • Nitrous Oxide

Interventions

DRUG

Nitrous oxide (N2O/O2)

Nitrous oxide (N2O/O2) for pain alleviation

DRUG

Oxygen (O2)

Oxygen (O2) as placebo for control group

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Israel

Study Locations

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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 NCT05579288 on ClinicalTrials.gov