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NCT04505657 Clinical Trial

Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography

IUCD Complication Clinical Trial

Official title:
Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04505657
Other study ID # aswu/351/5/19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date September 27, 2021

Study information
Verified date September 2021
Source Aswan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

our aims to investigate the effectiveness of10% Lidocaine Spray plus oral celecoxib for Pain Control During Hysterosalpingography

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 150
Est. completion date September 27, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - any patient came for Hysterosalpingography Exclusion Criteria: - any patient has contraindication to Hysterosalpingography

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• celecoxib plus lidocaine
Celecoxib 200 mg (Celebrex® 200, P?zer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure
• Celecoxib
Celecoxib 200 mg (Celebrex® 200, P?zer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure
• lidocaine
placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during 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 Mean pain score during the procedure Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores 10 minuets
See also
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Completed NCT04500015 - Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion Phase 4
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Completed NCT04500028 - Vaginal Isonicotinic Acid Hydrazide Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System Phase 4