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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00188071
Other study ID # CP 02-02
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated October 30, 2017
Start date September 2002
Est. completion date August 2003

Study information

Verified date September 2005
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

- To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the combination of these two analgesics

- each treatment beeing allocated by randomization


Description:

- 240 pregnant women who undewent a medical abortion by aspiration, under local anesthesia, (day case surgery) were enrolled after informed consent and signed approval

- according to randomization, they received one hour before medical abortion procedure performed under local anesthesia of the cervix, one of these three diffrente analgesics :

- paracetamol 1 gr

- ketoprofen 100 mg

- the association of both Postprocedure pain was recorded, by nurse, using a visual analog scale (VAS), 7 times before and after the procedure, until the discharge of the patient.

- if VAS was above 40 on two consecutive measurements a morphine injection was given.

- the number and total amount of morphine was recorded.

- satisfaction was recorded within the 3 postoperative day by a telephone inquiry.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date August 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- pregnant women

- medical abortion performed in day case surgery under local anesthesia

- informed written consent

Exclusion Criteria:

- under 18 year old

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
paracetamol

ketoprofen

ketoprofen + paracetamol


Locations

Country Name City State
France Dept of Anesthesia - CHU Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative pain rating
Secondary morphine consumption
Secondary patient satisfaction
See also
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Completed NCT00969982 - Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP)) N/A
Recruiting NCT02480543 - Different Routes of Misoprostol Prior to First Trimester Surgical Abortion Phase 4
Completed NCT00870272 - Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP) N/A
Completed NCT02048098 - Misoprostol for Second Trimester Termination of Pregnancy Phase 3
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