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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00769912
First received: October 8, 2008
Last updated: August 28, 2014
Last verified: January 2011
  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 3

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

Enrollment: 71
Study Start Date: October 2008
Study Completion Date: June 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
50% N2O- 50%O2 mixture administration during the intervention
Drug: 50% N2O- 50%O2 mixture
50% N2O- 50%O2 mixture administration
Placebo Comparator: 2
Placebo (air) during the intervention
Drug: Placebo (air)
Placebo administration during the intervention

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00769912     History of Changes
Other Study ID Numbers: 2008-000799-25, 2008-10
Study First Received: October 8, 2008
Last Updated: August 28, 2014
Health Authority: France: Ministry of Health

ClinicalTrials.gov processed this record on November 25, 2014