Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging
Intranasal Dexmedetomidine Sedation for Pediatric Computerized Tomography Imaging
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Invasive procedures for diagnosis in children are a routine part of an emergency care department. Most of these procedures are painful and uncomfortable for both the child and for their families, and impossible to be performed without patient immobilization. Thus, procedural sedation is critical to this end. Procedural sedation can be defined as the use of sedatives, analgesics, or dissociative drugs for anxiolysis, analgesia, sedation and motor control during painful procedures.
The increasing demand of pediatric emergency services and, consequently, the performance of procedures that require sedation, made it impossible for universal coverage of anesthesiologists in such procedures. As a result, a wide variety of drugs, sedation techniques and different degrees of effectiveness and adverse effects of sedation, such as irritability and sedation failure are described.
Particularly in children who need CT scan, there is usually no need for venous access for sedation. However, our most used drug, chloral hydrate, was abandoned in most centers outside the country. When administered orally, the drug produces malaise and vomiting, and gastric mucosal irritation, in addition, the rectal absorption is unpredictable. Additionally, in recent years increasing importance has been given to the fact that the drug be related, in vitro, the increased carcinogenicity in mice by cellular structural change, which is leading to the ban of same drug in the United States and in some european countries.
Dexmedetomidine is a highly selective alpha-2 agonist receptors, which has the advantage of mimicking natural sleep, according to electroencephalographic studies, with low incidence of adverse events. Its application as a sedative in pediatric procedures, as well as pre-anesthetic medication, has been increasingly described according to recent studies. The intranasal route has been used with the advantage of avoiding a venous line or intramuscular injection, with good results; however, it hasn't been described yet in children undergoing CT scans.
Thus, this work is justified to describe, in a pioneering way, the use of intranasal dexmedetomidine for sedation for CT, documenting its efficacy and safety in a specific cohort of patients sedated for this purpose.
연구 유형
연구 유형
등록 (예상)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Eduardo Mekitarian Filho, MD, PhD
- 전화번호: 919333 +55 11 30919333
- 이메일: emf2002@uol.com.br
연구 장소
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SP
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Sao Paulo, SP, 브라질, 05508000
- 모병
- University Hospital, University of Sao Paulo
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연락하다:
- Alfredo Gilio, MD, PhD
- 전화번호: 919409 +55 11 30919200
- 이메일: aegilio@uol.com.br
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수석 연구원:
- Eduardo Mekitarian Filho, MD, PhD
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Children between 1 month to 15 years old undergoing CT scans in the pediatric emergency department
Exclusion Criteria:
- Glasgow coma scale < 13
- Epistaxis or suspected base skull fracture
- Use of contrast or need for an IV line before sedation
- Uncontrolled gastroesophageal reflux or vomiting
- Current (or within past 3 months) history of apnea of prematurity requiring an apnea monitor
- Acute, unstable respiratory disease
- Unstable cardiac status
- Craniofacial anomaly
- Medication use: digoxin
- Moya Moya Disease
- New onset stroke
- American Society of Anesthesiologists physical status ≥3
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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Dexmedetomidine
All children undergoing
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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rates of sedation failure with intranasal dexmedetomidine for sedation for pediatric CT imaging
기간: Failure to sedate will be defined as non-completion of CT imaging after 2 nasal doses of dexmedetomidine (2.5 mcg/kg at admission; 0.5 mcg/kg after 15 minutes if not sedated).
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Main outcome for this research is to know if IN dexmedetomidine is effective for adequate sedation in children undergoing CT scannings.
This will be reported as percentage of failed sedations, if they occur.
Failed sedations will be defined if after a initial 2.5 mcg/kg dose along with another 0.5 mcg/kg dose after 15 minutes, the child does not sedate.
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Failure to sedate will be defined as non-completion of CT imaging after 2 nasal doses of dexmedetomidine (2.5 mcg/kg at admission; 0.5 mcg/kg after 15 minutes if not sedated).
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety of IN dexmedetomidine for pediatric CT imaging
기간: At admission and every 5 minutes after sedation
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Patients will be fully monitored every five minutes after IN dexmedetomidine administration, with heart rate, respiratory rate, non-invasive blood pressure and pulse oximetry.
Any adverse events will be reported.
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At admission and every 5 minutes after sedation
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 연구 책임자: Keira Mason, MD, Boston Children's Hospital, Harvard Medical School
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 시작
기본 완료 (예상)
기본 완료
연구 완료 (예상)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- USPDex
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