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

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ClinicalTrials.gov Identifier: NCT00769912
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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

Condition or disease Intervention/treatment Phase
Abortion Drug: 50% N2O- 50%O2 mixture Drug: Placebo (air) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Pain during the intervention [ Time Frame: 4 months ]

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


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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

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

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00769912     History of Changes
Other Study ID Numbers: 2008-000799-25
2008-10
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: January 2011