Clinical trial

Assessment of Flurbiprofen Tablet and Spray For Postoperative Pain Control In Oral Soft Tissue Wounds: A Randomized Clinical Trial

Name
05/25102023
Description
The amount of active ingredient in tablet form of flurbiprofen is higher than that in the oral spray form. Therefore, based on the hypothesis that the side effects that may occur depending on the dose can be reduced, this clinical study investigated whether tablet and spray form flurbiprofen would have similar effects on postoperative pain in primarily closed soft tissue wounds in the oral region.
Trial arms
Trial start
2023-10-26
Estimated PCD
2024-01-12
Trial end
2024-01-20
Status
Completed
Phase
Early phase I
Treatment
Flurbiprofen
The efficacy of two different forms and amounts of active ingredient (100mg tablet vs 25% oral spray) on postoperative pain of different flurbiprofen
Arms:
Spray group, Tablet group
Other names:
Spray flurbiprofen vs Tablet flurbiprofen
Size
40
Primary endpoint
Postoperative pain evaluation with Visual Analogue Scale (VAS) scores
One week (3, 6, 24, 48, and 72 hours and on the 5th and 7th days)
Eligibility criteria
Inclusion Criteria: * Provided that those using removable prosthesis had discontinued using the prosthesis 1 month ago (in order to minimize the lesion to be excised), healthy or ASA Class I patients between 40 and 65 years of age, who had the indication of pre-prosthetic surgery due to excision of epulis fissuratum and frenulum Exclusion Criteria: * Pregnancy, lactation, and taking contraceptive pills; being allergic to the drug or other NSAIDs to be used in the study; had used steroids or analgesic drugs for any reason for the last 1 month; using psychiatric drugs; those with incomplete data and refused to sign the consent form; those who were extremely afraid and had a gag reflex; those with any gastrointesinal problems; smoking, ASA-2 and ASA-3 patients and those who smoked.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The clinician collecting data from patients was blinded. The researcher who analyzed the results was blinded.', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2024-02-02

1 organization

1 product

3 indications

Indication
Drug Effect