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

Phase 3

Completed

• Conditions: Abortion
• Interventions: Drug: Placebo (air); Drug: 50% N2O- 50%O2 mixture

• Registration Number: NCT00769912
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Primary Completion: 2009-02
• Study Completion: 2009-06
• Status Verified: 2011-01
• Last Update Submitted: 2014-08-28
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo (air)	Placebo (air) during the intervention
1	50% N2O- 50%O2 mixture	50% N2O- 50%O2 mixture administration during the intervention

Primary Outcome Measures

Name	Time	Method
Pain during the intervention	4 months

Secondary Outcome Measures

Name	Time	Method
Pain at the end of the intervention and 2 hours after. Unwanted events	4 months

Trial Locations

Locations (1)

Service de Gynécologie Obstétrique, Hôpital La Conception; 🇫🇷 Marseille, France