Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia

Abortion Clinical Trial

Official title:

Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769912
• Other study ID #: 2008-000799-25
• Secondary ID: 2008-10
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2008
• Last updated: August 28, 2014
• Start date: October 2008
• Est. completion date: June 2009

Study information

• Verified date: January 2011
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To evaluate effectiveness of a prefixed 50% N2O- 50%O2 mixture in legal abortion under paracervical block.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Major patient having signed an assent waits having chosen to make the intervention under local anesthetic

Exclusion Criteria:

• Minor

• contraindication in the use of the paracetamol, the lidocaine

• Porphyries

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion

Intervention

Drug:
• 50% N2O- 50%O2 mixture
50% N2O- 50%O2 mixture administration
• Placebo (air)
Placebo administration during the intervention

Locations

Country	Name	City	State
France	Service de Gynécologie Obstétrique, Hôpital La Conception	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during the intervention		4 months	No
Secondary	Pain at the end of the intervention and 2 hours after. Unwanted events		4 months	No