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Comparative Evaluation of Transdermal and Oral Drugs for Management of Post-Endodontic Pain (PATCH-PAIN)

27 maja 2026 zaktualizowane przez: Dr Chitra Kumari, Nims University Rajasthan

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

80

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Indie
    • Rajasthan
      • Jaipur, Rajasthan, Indie, 303121
        • Department of Conservative Dentistry and Endodontics, Nims Dental College and Hospital, Nims University, Rajasthan

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Lek: 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.
Lek: 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.
Lek: 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.
Aktywny komparator: Fentanyl transdermal patch
A fentanyl 50 Mcg 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.
Lek: 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.
Lek: 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.
Lek: 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.
Aktywny komparator: 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.
Lek: 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.
Lek: 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.
Lek: 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.
Aktywny komparator: 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.
Lek: 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.
Lek: 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.
Lek: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Postoperative Pain Intensity from Baseline to 48 Hours Assessed by Visual Analog Scale (VAS)
Ramy czasowe: From immediately after endodontic treatment to 48 hours post-treatment
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.
From immediately after endodontic treatment to 48 hours post-treatment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Nims University Rajasthan

Śledczy

  • Główny śledczy: CHITRA KUMARI, MDS(pursuing), NIMS DENTAL COLLEGE AND HOSPITAL, NIMS UNIVERSITY, RAJASTHAN

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

18 kwietnia 2024

Zakończenie podstawowe (Rzeczywisty)

18 października 2025

Ukończenie studiów (Rzeczywisty)

18 października 2025

Daty rejestracji na studia

Pierwszy przesłany

20 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 maja 2026

Pierwszy wysłany (Rzeczywisty)

27 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IEC/P-541/2024

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data (IPD) will not be shared as the study involves patient-level clinical data collected during routine endodontic treatment. To ensure participant confidentiality and privacy, data will remain under the control of the study investigators and will not be made publicly available. Only aggregated and anonymized results will be reported in publications and presentations.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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