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

NCT ID: NCT00769912

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-06-30

Brief Summary

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

Detailed Description

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Conditions

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Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

50% N2O- 50%O2 mixture administration during the intervention

Group Type EXPERIMENTAL

50% N2O- 50%O2 mixture

Intervention Type DRUG

50% N2O- 50%O2 mixture administration

2

Placebo (air) during the intervention

Group Type PLACEBO_COMPARATOR

Placebo (air)

Intervention Type DRUG

Placebo administration during the intervention

Interventions

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50% N2O- 50%O2 mixture

50% N2O- 50%O2 mixture administration

Intervention Type DRUG

Placebo (air)

Placebo administration during the intervention

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aubert AGOSTINI, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique des Hopitaux de Marseille

Locations

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Service de Gynécologie Obstétrique, Hôpital La Conception

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2008-10

Identifier Type: -

Identifier Source: secondary_id

2008-000799-25

Identifier Type: -

Identifier Source: org_study_id

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