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Comparative Evaluation of Transdermal and Oral Drugs for Management of Post-Endodontic Pain
Sponsor: Nims University Rajasthan
Summary
This clinical trial evaluated whether two drugs delivered through transdermal drug delivery systems reduced post-endodontic pain as effectively as two orally administered medications in adult patients undergoing root canal treatment. The study also compared how effectively these medications controlled pain during the first 48 hours after treatment. The study aimed to answer the following questions: Did transdermal drug delivery systems provide pain relief comparable to or better than orally administered medications after endodontic treatment? Did pain intensity differ among the four treatment groups as measured using the Visual Analog Scale (VAS)? The investigators compared two transdermal drug groups with two oral drug groups to identify the treatment that provided better control of post-endodontic pain. Participants: Underwent root canal treatment for symptomatic irreversible pulpitis. Received one of four analgesic interventions consisting of two transdermal patches or two oral medications. Recorded pain intensity using the Visual Analog Scale (VAS) at 6, 12, 24, and 48 hours after treatment.
Official title: Comparative Evaluation of Two Different Drugs Administered Using Transdermal Drug Delivery Route Versus Two Oral Tablets in Management of Post-Endodontic Pain
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-04-18
Completion Date
2025-10-18
Last Updated
2026-05-29
Healthy Volunteers
No
Conditions
Interventions
Ketoprofen transdermal patch
A ketoprofen 30 mg transdermal patch is applied to intact skin immediately after a single-sitting endodontic treatment. The patch was replaced after 24 hours, with a total of two patches used over 48 hours to provide continuous non-steroidal anti-inflammatory analgesia through sustained transdermal drug delivery. Each patch was applied once daily without overlap. Patients were monitored for postoperative pain relief and any local skin reactions during the 48-hour follow-up period.
Fentanyl transdermal patch
A fentanyl 50-Mcg transdermal patch is applied to intact skin immediately after endodontic treatment. The patch was applied once and maintained in place for 48 hours to provide continuous opioid analgesia through controlled systemic transdermal drug delivery. No patch replacement or re-dosing was performed during the study period. Patients were monitored over 48 hours for postoperative pain relief and potential adverse effects such as nausea, dizziness, sedation, or local skin reactions.
Diclofenac sodium tablet
A diclofenac sodium 50 mg tablet was administered orally every 8 hours for 48 hours following endodontic treatment in adult patients. The drug was given at standard therapeutic dosages for postoperative analgesia. No additional analgesics were routinely provided unless rescue medication was required. Patients were monitored during the 48-hour period for pain relief and potential adverse effects such as gastric discomfort, nausea, or dizziness.
Ibuprofen Tablet
An ibuprofen 400 mg tablet was administered orally every 8 hours for 48 hours following endodontic treatment for postoperative pain management. The drug was given at standard therapeutic dosages as an analgesic and anti-inflammatory agent. No routine additional analgesics were provided unless rescue medication was required. Patients were monitored over the 48-hour period for pain relief and potential adverse effects such as gastric irritation, nausea, or dizziness.
Locations (1)
Department of Conservative Dentistry and Endodontics, Nims Dental College and Hospital, Nims University, Rajasthan
Jaipur, Rajasthan, India