- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02248493
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Kaunas, 리투아니아, 50009
- Lithuanian University of Health Sciences Kaunas Clinics
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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. |
다른 이름들:
다른 이름들:
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.
다른 이름들:
administered in patients receiving IV PCA with morphine postoperatively.
No other opioid is given to these patients.
|
위약 비교기: 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. |
다른 이름들:
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.
다른 이름들:
administered in patients receiving IV PCA with morphine postoperatively.
No other opioid is given to these patients.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
change in postoperative intravenous opioid dose
기간: 24 hours postoperatively
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24 hours postoperatively
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2차 결과 측정
결과 측정 |
기간 |
---|---|
change in pain level (analgesia) assessed by 10 point pain scales
기간: 1 hour postoperatively
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1 hour postoperatively
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change in pain level (analgesia) assessed by 10 point pain scales
기간: 24 hours postoperatively
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24 hours postoperatively
|
기타 결과 측정
결과 측정 |
기간 |
---|---|
time until the first oral intake after surgery
기간: 24 hours postoperatively
|
24 hours postoperatively
|
time until the first urination after surgery
기간: 24 hours postoperatively
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24 hours postoperatively
|
time until ambulation after surgery
기간: 24 hours postoperatively
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24 hours postoperatively
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Danguole C Rugyte, MD. PhD, Lithuanian University of Health Sciences
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BEC-MF-10
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