Effectiveness of Opioid vs Pregabalin Plus Naproxen Sodium in Pain Management of Oral Cancer Patients
This randomized clinical study was designed to compare two pain treatment approaches for adults with oral cancer who had moderate to severe pain. Oral cancer pain may occur because of tumor growth, local tissue damage, inflammation, ulceration, or nerve involvement. Standard pain treatment often includes opioid medicines, but these medicines may cause side effects such as sedation, nausea, constipation, dizziness, tolerance, or dependence. In some patients, pain may also have a nerve-related or inflammatory component, where medicines such as pregabalin and naproxen sodium may provide additional benefit.
A total of 98 eligible adult patients with histopathology-confirmed oral cancer and a baseline Visual Analog Scale pain score of 4 or more were included. Patients were randomly assigned into two treatment groups. One group received oral tramadol 50 mg every 4 hours, with dose adjustment according to pain relief and tolerability. The other group received oral pregabalin 75 mg twice daily with naproxen sodium 550 mg twice daily. Both treatments were given for 7 days under clinical monitoring.
Pain intensity was measured using the Visual Analog Scale at baseline, day 3, and day 7. The main outcome was the mean reduction in pain score from baseline to day 7. Effective pain relief was defined as at least 50% reduction in the baseline pain score after 7 days of treatment. Side effects such as sedation, nausea or vomiting, constipation, dizziness, and gastrointestinal discomfort were also recorded. Patient satisfaction with pain control was assessed at the end of treatment.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Punjab Province
-
Lahore、Punjab Province、パキスタン、54000
- Mayo Hospital, Lahore
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients aged 18 years or older
- Histopathology confirmed diagnosis of oral cancer
- Experiencing moderate to severe pain (VAS ≥ 4)
- Either opioid-naïve or off opioids for at least one week
- Able to provide informed consent
Exclusion Criteria:
- Known allergy to morphine, pregabalin, or NSAIDs
- History of renal impairment, gastrointestinal bleeding, or peptic ulcer disease
- Concurrent use of other strong analgesics
- Psychiatric illness or cognitive impairment interfering with pain assessment
- Pregnancy or lactation
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Group A Tramadol
Received oral tramadol 50 mg every 4 hours for pain management.
Dose titration was done according to pain relief and tolerability.
Treatment was continued for 7 days with clinical monitoring for pain response and adverse effects.
|
Oral tramadol 50 mg was administered every 4 hours for 7 days.
Dose adjustment was made according to clinical response and tolerability.
|
|
実験的：Group B Pregabalin Plus Naproxen Sodium
Received oral pregabalin 75 mg twice daily along with oral naproxen sodium 550 mg twice daily for pain management.
Treatment was continued for 7 days with clinical monitoring for pain response and adverse effects.
|
Oral pregabalin 75 mg was administered twice daily for 7 days.
Oral naproxen sodium 550 mg was administered twice daily for 7 days.
|
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 |
|---|---|---|
|
Mean Change in Visual Analog Scale Pain Score From Baseline to Day 7
時間枠：Baseline and Day 7
|
Pain intensity was assessed using the Visual Analog Scale, ranging from 0 to 10, where 0 indicated no pain and 10 indicated the worst imaginable pain.
The mean change in pain score was calculated by subtracting the day 7 Visual Analog Scale score from the baseline Visual Analog Scale score.
A greater positive change indicated greater reduction in pain intensity.
The mean change was compared between the tramadol group and the pregabalin plus naproxen sodium group.
|
Baseline and Day 7
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Effective Pain Relief at Day 7
時間枠：Baseline to Day 7
|
Effective pain relief was defined as at least 50% reduction in the baseline Visual Analog Scale pain score after 7 days of treatment.
The proportion of participants achieving effective pain relief was compared between the two treatment groups.
|
Baseline to Day 7
|
|
Severity of Adverse Events
時間枠：Day 0 to Day 7
|
The severity of adverse events was assessed using the Common Terminology Criteria for Adverse Events version 5.0.
Events were categorized according to severity grade and compared between the treatment groups.
|
Day 0 to Day 7
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Rooshan Tahir Qazi、Mayo Hospital Lahore
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- Mayo6
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。