Intravenous Paracetamol for Postoperative Pain (IVPARACET)
The Effect of Intravenous Paracetamol in Combination With NSAIDs for Postoperative Pain in Children
The purpose of this study is to define if intravenous paracetamol may improve analgesia and outcome in pediatric surgical patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) postoperatively.
Hypothesis: intravenous paracetamol in a dose 60 mg/kg/24 h IV, given in addition to IV ketoprofen (4,5 mg/kg/24h), improves analgesia and physical recovery in children and adolescents following surgery.
調査の概要
詳細な説明
Patients aged 1-18 years undergoing general, plastic or orthopedic surgery with expected moderate to severe pain at least for 24 hours postoperatively, who meet inclusion criteria and does not meet exclusion criteria, are enrolled. At the end of surgical procedure, at skin closure, all patients are given 1,5 mg/kg intravenous ketoprofen and repeated every 8 hours up till 4,5 mg/kg/24 h. Patients in paracetamol group are additionally given the first dose of IV paracetamol 20 mg/kg and repeated 6 and 20 hours postoperatively up till 60 mg/kg/24 h. Patients in the placebo group are given 0.9% sodium chloride 2 ml/kg IV and repeated 6 and 20 hours postoperatively.
After surgery optional rescue analgesia is given on patient request: either tramadol in a dose of 2 mg/kg (up till 4 mg/kg/24h), either patient-controlled analgesia (PCA) with morphine, as indicated according to the standard of care. Patients are evaluated up till 24 hours postoperatively. After that patients are followed up as long as indicated per standard of care.
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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Kaunas、リトアニア、50009
- Lithuanian University of Health Sciences Kaunas Clinics
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients 1-18 years of age, undergoing general, plastic or orthopedic surgery with expected median to severe pain postoperatively.
- physical status of the patient corresponding to American Society of Anesthesiologists (ASA) class 1 or 2
- Signed written informed consent by parents/official caregivers.
Exclusion Criteria:
- Allergy to paracetamol, ketoprofen, tramadol, morphine or any NSAID
- oncologic disease
- central nervous system disease
- renal dysfunction
- hepatic dysfunction
- bronchial asthma
- ulcer(s) in gastrointestinal system
- hemorrhagic diathesis
- chronic use of NSAIDs
- chronic use of opioids
- chronic use of anticoagulants
- female patient is known to be pregnant
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：paracetamol and ketoprofen
paracetamol 20 mg/kg (1% 2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter. ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively. |
他の名前：
他の名前：
Administered on request as rescue medication in a dose 2 mg/kg IV up till 2 doses.
No other opioid is given to these patients.
他の名前：
administered in patients receiving IV PCA with morphine postoperatively.
No other opioid is given to these patients.
|
|
プラセボコンパレーター：placebo and ketoprofen
0.9% sodium chloride (2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter. ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively. |
他の名前：
Administered on request as rescue medication in a dose 2 mg/kg IV up till 2 doses.
No other opioid is given to these patients.
他の名前：
administered in patients receiving IV PCA with morphine postoperatively.
No other opioid is given to these patients.
他の名前：
|
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 |
時間枠 |
|---|---|
|
change in postoperative intravenous opioid dose
時間枠：24 hours postoperatively
|
24 hours postoperatively
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
change in pain level (analgesia) assessed by 10 point pain scales
時間枠：1 hour postoperatively
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1 hour postoperatively
|
|
change in pain level (analgesia) assessed by 10 point pain scales
時間枠：24 hours postoperatively
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24 hours postoperatively
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
time until the first oral intake after surgery
時間枠：24 hours postoperatively
|
24 hours postoperatively
|
|
time until the first urination after surgery
時間枠：24 hours postoperatively
|
24 hours postoperatively
|
|
time until ambulation after surgery
時間枠：24 hours postoperatively
|
24 hours postoperatively
|
協力者と研究者
捜査官
- 主任研究者：Danguole C Rugyte, MD. PhD、Lithuanian University of Health Sciences
出版物と役立つリンク
一般刊行物
- Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
- Wong I, St John-Green C, Walker SM. Opioid-sparing effects of perioperative paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) in children. Paediatr Anaesth. 2013 Jun;23(6):475-95. doi: 10.1111/pan.12163. Epub 2013 Apr 9.
- Hiller A, Silvanto M, Savolainen S, Tarkkila P. Propacetamol and diclofenac alone and in combination for analgesia after elective tonsillectomy. Acta Anaesthesiol Scand. 2004 Oct;48(9):1185-9. doi: 10.1111/j.1399-6576.2004.00473.x.
- Rugyte D, Kokki H. Intravenous ketoprofen as an adjunct to patient-controlled analgesia morphine in adolescents with thoracic surgery: a placebo controlled double-blinded study. Eur J Pain. 2007 Aug;11(6):694-9. doi: 10.1016/j.ejpain.2006.11.001. Epub 2006 Dec 20.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
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