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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Rajasthan
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Jaipur、Rajasthan、インド、303121
- Department of Conservative Dentistry and Endodontics, Nims Dental College and Hospital, Nims University, Rajasthan
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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アクティブコンパレータ：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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アクティブコンパレータ：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Postoperative Pain Intensity from Baseline to 48 Hours Assessed by Visual Analog Scale (VAS)
時間枠：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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協力者と研究者
捜査官
- 主任研究者：CHITRA KUMARI, MDS(pursuing)、NIMS DENTAL COLLEGE AND HOSPITAL, NIMS UNIVERSITY, RAJASTHAN
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IEC/P-541/2024
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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