Postoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen

Abortion, Induced Clinical Trial

Official title:

Postoperative Pain After Medical Abortion Under Local Anesthesia : a Prospective and Randomized Trial Comparing Several Analgesic Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188071
• Other study ID #: CP 02-02
• 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
• 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
• 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

Related Conditions & MeSH terms

• Abortion, Induced
• Pain, Postoperative

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