Comparative Evaluation of Transdermal and Oral Drugs for Management of Post-Endodontic Pain (PATCH-PAIN)
Comparative Evaluation of Two Different Drugs Administered Using Transdermal Drug Delivery Route Versus Two Oral Tablets in Management of Post-Endodontic Pain
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Post-endodontic pain is a common consequence of root canal treatment and is primarily associated with the release of inflammatory mediators in the periapical tissues following instrumentation and obturation. Analgesic medications are routinely prescribed to reduce pain during the immediate postoperative period. Conventional oral administration is effective but may be associated with gastrointestinal adverse effects and variability in drug absorption. Transdermal drug delivery systems provide sustained release of medication through the skin, maintain relatively stable plasma concentrations, and may improve patient compliance while reducing systemic adverse effects.
This randomized, parallel-group clinical trial was conducted to compare the effectiveness of two transdermal medications, fentanyl patch and ketoprofen patch, with two orally administered medications, diclofenac and ibuprofen, in the management of post-endodontic pain. A total of 80 participants undergoing single-sitting root canal treatment were enrolled and randomly allocated into four equal groups of 20 participants each.
Participants in Group I received a transdermal fentanyl patch; Group II received a transdermal ketoprofen patch; Group III received oral diclofenac tablets; and Group IV received oral ibuprofen tablets according to the study protocol. All interventions were administered after completion of endodontic treatment.
The study was designed to determine whether transdermal administration of analgesic agents could provide pain control comparable to or better than conventional oral therapy during the early postoperative period following root canal treatment. The findings were intended to contribute to evidence-based recommendations regarding alternative routes of analgesic administration for the management of post-endodontic pain in clinical endodontic practice.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Rajasthan
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Jaipur, Rajasthan, India, 303121
- Department of Conservative Dentistry and Endodontics, Nims Dental College and Hospital, Nims University, Rajasthan
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients aged 18 to 60 years
- Patients diagnosed with symptomatic irreversible pulpitis or symptomatic apical periodontitis
- Multi-rooted teeth indicated for single-visit root canal treatment
- Patients experiencing moderate to severe preoperative pain
- Systemically healthy individuals
- Patients willing to participate and comply with follow up protocol
Exclusion Criteria:
- Patients with a known history of hypersensitivity or adverse reactions to diclofenac, ketoprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), including reactions such as bronchospasm, shock, or urticaria, were excluded from the study.
- Individuals with a history of active gastric or duodenal ulceration within the previous six months were not included.
- Patients who were currently receiving NSAIDs or corticosteroid therapy during the study period were excluded.
- Participants with a medical history of systemic conditions such as bronchial asthma, epilepsy, inflammatory bowel disease, severe hepatic or renal impairment, dengue fever, or any psychological or psychiatric disorders were not considered eligible for inclusion.
- Pregnant and lactating women were excluded from the study.
- Patients with a history of antibiotic use during the study period were also excluded.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Ketoprofen transdermal patch
A ketoprofen 30 mg transdermal patch was applied once to intact skin immediately after endodontic treatment in adult patients.
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 local skin reactions during the 48-hour follow-up period.
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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.
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Comparador activo: Diclofenac sodium tablet
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 a standard therapeutic dose for postoperative analgesia and anti-inflammatory effect.
No additional routine 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.
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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.
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Comparador activo: Ibuprofen Tablet
Ibuprofen 400 mg tablet was administered orally every 8 hours for 48 hours following endodontic treatment in adult patients for postoperative pain management.
The drug was given at standard therapeutic dosing for analgesic and anti-inflammatory effects.
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.
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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.
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Comparador activo: Fentanyl transdermal patch
A 25 mcg fentanyl transdermal patch was applied once to intact skin immediately after endodontic treatment in adult patients.
The patch was 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 during the 48-hour follow-up for postoperative pain relief and potential adverse effects such as nausea, dizziness, sedation, and local skin reactions.
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A fentanyl 25-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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Postoperative Pain Intensity from Baseline to 48 Hours Assessed by Visual Analog Scale (VAS)
Periodo de tiempo: From immediately after endodontic treatment to 48 hours post-treatment
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Postoperative pain intensity was assessed as the primary outcome using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Pain scores were recorded at predefined time intervals following endodontic treatment, including baseline (immediately after the procedure) and at 6, 12, 24, and 48 hours postoperatively.
Data were collected via patient self-report, primarily through telephone follow-up.
The primary endpoint for analysis was the pain intensity at 48 hours after treatment, comparing the effectiveness of the four analgesic interventions in reducing postoperative endodontic pain.
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From immediately after endodontic treatment to 48 hours post-treatment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: CHITRA KUMARI, MDS(pursuing), NIMS DENTAL COLLEGE AND HOSPITAL, NIMS UNIVERSITY, RAJASTHAN
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IEC/P-541/2024
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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