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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00769912
Other study ID # 2008-000799-25
Secondary ID 2008-10
Status Completed
Phase Phase 3
First received October 8, 2008
Last updated August 28, 2014
Start date October 2008
Est. completion date June 2009

Study information

Verified date January 2011
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date June 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
50% N2O- 50%O2 mixture
50% N2O- 50%O2 mixture administration
Placebo (air)
Placebo administration during the intervention

Locations

Country Name City State
France Service de Gynécologie Obstétrique, Hôpital La Conception Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain during the intervention 4 months No
Secondary Pain at the end of the intervention and 2 hours after. Unwanted events 4 months No
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