Status:
WITHDRAWN
Nitrous Oxide for Pain Management During IUD Insertion in Nulliparous Adolescent Women
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Praxair Distribution, Inc.
Conditions:
Contraceptive Devices
Long-Acting Reversible Contraception
Eligibility:
FEMALE
14-24 years
Phase:
PHASE2
PHASE3
Brief 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 ad...
Detailed Description
The objective of this research study is to learn more about how to make the intrauterine device (IUD) insertion procedure more comfortable. IUDs are highly effective at preventing pregnancy and are al...
Eligibility Criteria
Inclusion
- nulliparous (no pregnancy of 24 weeks' duration or longer and not currently pregnant)
- adolescent females (14-24 years)
Exclusion
- use of opioids, benzodiazepines, or marijuana within the past 24 hours
- failure to meet medical eligibility criteria for an IUD
- medical contraindications to NSAID use
- relative contraindications to N2O administration, including severe pulmonary disease, congenital heart disease, diseases associated with vitamin B12 deficiency, and sickle cell disease
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04089852
Start Date
June 1 2021
End Date
November 1 2021
Last Update
September 16 2022
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115