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

This study is ongoing, but not recruiting participants.

Sponsored by:	Assistance Publique Hopitaux De Marseille
Information provided by:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00769912

Purpose

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

Condition	Intervention	Phase
Abortion	Drug: 50% N2O- 50%O2 mixture Drug: Placebo (air)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:

Pain during the intervention [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain at the end of the intervention and 2 hours after. Unwanted events [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 50% N2O- 50%O2 mixture administration during the intervention	Drug: 50% N2O- 50%O2 mixture 50% N2O- 50%O2 mixture administration
2: Placebo Comparator Placebo (air) during the intervention	Drug: Placebo (air) Placebo administration during the intervention

Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769912

Locations

France
Service de Gynécologie Obstétrique, Hôpital La Conception
MARSEILLE, France, 13005

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator:

Aubert AGOSTINI, MD

Assistance Publique des Hopitaux de Marseille

More Information

Responsible Party:	Assistance Publique Hopitaux De Marseille ( Assistance Publique Hopitaux De Marseille )
Study ID Numbers:	2008-000799-25, 2008-10
Study First Received:	October 8, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00769912
Health Authority:	France: Ministry of Health

ClinicalTrials.gov processed this record on January 15, 2009