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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04500470
Other study ID # aswu/351/3/19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date September 1, 2021

Study information

Verified date January 2022
Source Aswan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of our study is to determine the efficacy of Ketoprofen with or without vaginal isonicotinic acid hydrazide on the pain scores during HSG.


Description:

hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 1, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - any patient came for Hysterosalpingography Exclusion Criteria: - any patient has contraindication to HSG

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ketoprofen + INH
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure
Ketoprofen + placebo
patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table placebo by the patient 12 hours before the procedure

Locations

Country Name City State
Egypt Aswan University Hospital Aswan

Sponsors (1)

Lead Sponsor Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intensity of pain pain during the procedure assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable 15 minutes
Secondary Intensity of pain Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10 30 minutes after the procedure
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