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Comparison of postoperative pain after day care surgeries using a pain patch on skin versus an oral pain tablet

Comparative evaluation of transdermal ketoprofen patch versus oral ketoprofen tablet in managing post-operative pain of day care oral surgery patients- A non-inferiority, randomised clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096661
Enrollment
52
Registered
2025-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: TRANSDERMAL KETOPROFEN PATCH: HALF OF THE PATIENTS WOULD BE SUBJECTED TO TRANSDERMAL KETOPROFEN PATCH 30 MG ONCE DAILY Control Intervention1: TABLET KETOPROFEN: HALF OF THE POPULATION W

Sponsors

Debapriya Mahata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients within the age group of 18-60 years and scheduled for day care oral surgeries. 2. ASA-I & II Patients. 3. Patients in the weight range of 50-80 kgs. 4. Patients who give consent for the study.

Exclusion criteria

Exclusion criteria: 1. History of allergy to the drug to be used in this study. 2. All pregnant and lactating females. 3. Duration of surgery less than 30 minutes or more than 2 hours from incision to closure. 4. Subjects with any associated history of bleeding disorder, allergy to NSAIDs, bronchial asthma, peptic ulcers, history of liver or kidney disease, abuse of drugs and alcohol

Design outcomes

Primary

MeasureTime frame
To evaluate and compare the pain score postoperatively in day care oral surgery patients for seven consecutive days after patch placement and drug intervention by using Numerical pain rating scale at rest and during movement of jaws as in chewing which is dynamic painTimepoint: 7 days

Secondary

MeasureTime frame
To evaluate and compare the number of rescue medications consumedTimepoint: 7 days;To evaluate and compare the episodes of adverse events of the drug including nausea, vomiting, gastrointestinal upset, constipation(difficult bowel movements) and application site reactionTimepoint: 7 days;To assess and compare quality of recovery postoperatively using QOR15 scaleTimepoint: 24 hours, 48 hours and 7 days post-operatively

Countries

India

Contacts

Public ContactDebapriya Mahata

PGIMER, Chandigarh

satnamsurgeon@gmail.com9914287909

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026