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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:
ClinicalTrials.gov Identifier:
NCT00769912
First Posted: October 9, 2008
Last Update Posted: August 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Pain at the end of the intervention and 2 hours after. Unwanted events [ Time Frame: 4 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00769912     History of Changes
Other Study ID Numbers: 2008-000799-25
2008-10
First Submitted: October 8, 2008
First Posted: October 9, 2008
Last Update Posted: August 29, 2014
Last Verified: January 2011