Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty
Evaluation of the Analgesic Effect of Tramadol Wound Infiltration in Children Under Inguinal Hernioplasty. A Double-blind, Randomized Study.
Tramadol is a centrally acting analgesic, is primarily Indicated for the treatment of acute pain, moderate to severe. The hernioplasty in children is an outpatient procedure, and the possibility of postoperative analgesia with fewer systemic adverse effects such as nausea and vomiting make the tramadol infiltration a technique of interest. There is controversy about its effectiveness.
The local effect of tramadol in hernioplasty was also studied by researchers with some better postoperative analgesia than with local anestetic .
There are few studies with administration of tramadol for hernioplasty, Which led to the interest in this study.
연구 개요
상세 설명
The primary objective of the study was to evaluate the analgesic effect of tramadol injected into the surgical incision in patients undergoing hernioplasty.
The study is a prospective, comparative, double covered. The distribution of patients in the groups was randomly drawn prior to starting the project and the groups were identified in envelopes numbered 1-40.
Criteria for inclusion and exclusion After approval by the Ethics Committee of UNIFESP and signature of consent by those responsible, and the term of assent by patients over six years, 40 children of both sexes will be evaluated, aged between 3 and 12 years who underwent hernioplasty.
Children with bleeding disorders, using analgesic or sensitivity to any drug will be excluded.
The patients will be randomly divided into one of two groups. Patients in group 1 will receive local infiltration with 2 mg / kg of tramadol diluted in 5 ml of 0.9% saline solution and 20ml of 0.9% saline solution intravenously at the end of the surgical procedure Patients in group 2 will receive 2 mg.kg-1 tramadol intravenously diluted in 20 ml of 0.9% saline solution and local infiltration with 5 mL of saline solution 0.9% at the end of the surgical procedure.
All patients will undergo general anesthesia, and will receive additional analgesia with dipyrone and morphine as needed in post operative period.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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São Paulo, 브라질, 04023062
- São Paulo Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- children of both sexes
- aged between 3 and 12 years
- underwent hernioplasty
Exclusion Criteria:
- children with bleeding disorders
- using analgesic
- sensitivity to any drug.
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 |
|---|---|
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활성 비교기: tramadol wound infiltration
2 mg / kg of tramadol diluted in 5 ml of 0.9% saline solution wound infiltration 20ml of 0.9% saline solution intravenously
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The volume of the solution was adequate to maintain the concentration of 2% tramadol
다른 이름들:
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실험적: tramadol intravenous administration
2 mg / kg of tramadol diluted 20ml of 0.9% saline solution intravenously 5 ml of 0.9% saline solution wound infiltration
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The volume of the solution was adequate to maintain the concentration of 2% tramadol
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain intensity after wound infiltration with tramadol
기간: 1 month
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Faces scale
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1 month
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ana LA Giraldes, MD, Federal University of São Paulo
간행물 및 유용한 링크
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 187177
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