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

The study design would be a randomized, parallel, double blind, double dummy noninferiority,

randomised clinical trial wherein the subjects would be recruited from the

outpatients scheduled for day care oral surgeries at the Unit of Oral and Maxillofacial

Surgery, Oral Health Sciences Centre, Postgraduate Institute of Medical Education and

Research, Chandigarh. Written informed consent would be obtained from all the patients

participating in the study after providing complete study information. Patients satisfying the

inclusion listed above would be randomized to receive either transdermal ketoprofen patch of

30mg per 70 sq.cm that is to be changed every 24 hours and placebo tablets or oral ketoprofen

tablets of 100mg BD and placebo patch. The patients would be randomized using computer

generated random numbers to avoid selection bias. Each patient would be given a particular

ID no. Both the patch and tablet would be identical to their respective placebos to avoid any

physical difference. All patients would receive Tab Rantac 150 mg as premedication, the

night before surgery. On the day of surgery, patient and attendant would be explained

about the procedure and postoperative instructions. Patch would be applied before intubation

and oral drug would be given 2 hours post-operatively with a sip of water. A standard general

anaesthetic technique would be followed in all patients.

Intensity of pain would be recorded using NRS scoring of 0-10, in all the subjects and

postoperatively at periods of Day 1, 2, 3, 4, 5, 6 and 7, every 11 hours after consumption of

oral Ketoprofen tablets, at rest and on movement of jaws. The allocation of drugs would be

performed by another personnel who would neither participate in the surgical procedure nor

in the evaluation of outcomes. Both the investigator and the patient would be blinded to the

form of active drug being provided to the patient till the end of the study. For each ID No.

Patients would be given a plastic pouch containing patches and a plastic container having

tablets with the sticker mentioning patient’s ID and instructions on how to apply or consume the

medication. In every pouch and container, only one of it would have active drug and the other

a placebo. Therefore, each patient would receive only one active form of drug in either patch

or tablet form. Each plastic pouch would contain 7 patches and each plastic container 14

tablets.Additionally, 10 tablets of paracetamol 650 mg would be handed over to the patients as a

rescue medication to be consumed, if required, by the patients in either of the groups if pain

control is not achieved even after taking the prescribed medications . Pain would be

assessed post-operatively on Day 1, 2, 3, 4, 5, 6 and 7 and noted. Instructions on how to note down the details of the events would be verbally explained to the patient by the investigator.The possible adverse events of the given drug would be mentioned on the patient’s diary along with NRS and patients would be informed to note their episodes whenever occurred.

Patients would be asked to mention the number of rescue tablets taken in the given diary.

Patients would complete the QoR-15 scoring at 24 hours, 48 hours and seven days post-operatively.