- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07928947
Lactium Versus Midazolam Premedication on Postoperative Negative Behavioral Changes
Effect of Lactium Versus Midazolam Premedication on Postoperative Negative Behavioral Changes in Children Undergoing Adenotonsillectomy: A Randomized Double-blind Placebo-controlled Trial
This prospective randomized double-blind placebo-controlled study will be conducted to compare the effects of preoperative oral lactium and midazolam on the incidence of postoperative negative behavioral changes in young children undergoing adenotonsillectomy.
연구 개요
상태
상세 설명
Pre-anesthetic sedation may reduce postoperative negative behavioral changes. Midazolam, a benzodiazepine receptor agonist, has been used in attempts to improve child cooperation with anesthesia induction, though with reported variation in effectiveness for benefit at the different stages in the pre-, intra-, and postoperative periods. Lactium" is a synthetic derivative of alpha-s1 casein hydrolysate (ACH) containing the alpha-casozepine peptide, which is one of the main components of milk protein. It has been shown to interact with gamma-aminobutyric acid A receptors to provide anxiolytic and anti-stress effects. In this novel study, we hypothesize that the pre-emptive premedication by oral administration of lactium or midazolam can decrease the incidence of negative behavioral changes in children undergoing adenotonsillectomy.
연구 유형
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Osama M Rehab, MD
- 전화번호: 002 01095210806
- 이메일: osamarehab@med.tanta.edu.eg
연구 장소
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Gharbia Governorate
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Tanta, Gharbia Governorate, 이집트, 31527
- Tanta University Hospitals
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연락하다:
- Osama M Rehab, MD
- 전화번호: 002 01095210806
- 이메일: osamarehab@med.tanta.edu.eg
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children aged 3 to 12 years.
- American Society of Anesthesiologists (ASA) Physical Status I or II.
- scheduled for adenotonsillectomy under sevoflurane general anesthesia.
Exclusion Criteria:
- Parents declined to participate in the trial,
- Children with behavioral changes; neurological or psychiatric diseases
- Physical or developmental delay;
- Sedative or anticonvulsant medication;
- Pre-existing renal or cardiovascular disease.
- Allergy to midazolam or lactose.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Lactium group
Cases will receive preoperative lactium (5 mg/kg). Each lentra sachet (containing 150 mg Lactium) will be totally dissolved in 60 ml water and (2 ml/kg) will be given to cases, 2 hours before surgery with a maximum dose of 300 mg. |
cases will receive preoperative lactium, each lentra sachet (containing 150 mg Lactium) will be totally dissolved in 60 ml water and 5 mg/kg (2 ml/kg) will be given to cases, 2 hours before surgery with a maximum dose of 300 mg. Also, they will receive volume matched and flavored matched water 30 minutes before surgery. The cups and the syringes will be opaque. |
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실험적: Midazolam group
Cases will receive preoperative 0.5 mg/kg oral midazolam (maximum 20 mg), 30 minutes before surgery. |
cases will receive 2 ml/kg of water dissolved into it a sweet- vanilla flavored powder, 2 hours before surgery. Also, 0.5 mg/kg oral midazolam (maximum 20 mg) will be given 30 minutes before surgery. |
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위약 비교기: Control group
Cases will receive volume matched flavored solutions at each corresponding time point. |
Cases will receive volume matched and flavored matched oral solution at each corresponding time point. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of negative behavioral changes at 24-h following surgery.
기간: 24 hours after surgery.
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It will be assessed by a validated Arabic version of the Post Hospitalization Behavior Questionnaire (PHBQ). This is a 27-item questionnaire that was used to evaluate the child's behavior. Significant negative behavioral changes will be defined as ≥ 7 negative changes on the PHBQ items in comparison with the pre-anesthesia baseline values. |
24 hours after surgery.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of negative behavioral changes at 3, 7, 14, 30 days following surgery.
기간: Up to 1 month after surgery
|
It will be assessed by a validated Arabic version of the Post Hospitalization Behavior Questionnaire (PHBQ). This is a 27-item questionnaire that was used to evaluate the child's behavior. Significant negative behavioral changes will be defined as ≥ 7 negative changes on the PHBQ items in comparison with the pre-anesthesia baseline values. |
Up to 1 month after surgery
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Incidence of emergence delirium.
기간: Up to 1 hour after surgery.
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It will be evaluated using the Pediatric Anesthesia Emergence Delirium scale (PAED) scale. A score >12 together with a Delirium-specific score ≥ 9 will be considered a diagnostic endpoint for the development of delirium. |
Up to 1 hour after surgery.
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Parent separation anxiety.
기간: Perioperative.
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It will be assessed at the time of taking the child to the operating theatre by the attending anesthesiologist using the Parent Separation Anxiety Scale (PSAS). (13) The PSAS ranges from one to four where one refers to easy separation; two equals whimpers; three denotes that the child cries and cannot be easily reassured but not clinging to parents; and 4 signifies crying and clinging to parents. A PSAS score of 1 or 2 was considered as 'acceptable' separation. |
Perioperative.
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Mask acceptance.
기간: Perioperative.
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The ease of mask acceptance will be graded using the Mask Acceptance Score (MAS) at the time of induction of general anesthesia with sevoflurane. (14) The MAS scale is a 4-point Likert scale: 1 = excellent (unafraid, accepts mask readily); 2 = good (slight fear of mask, easily reassured); 3 = fair (moderate fear of mask, not calmed with reassurance); and 4 = poor (terrified, combative and crying). A MAS of 1 or 2 was considered 'satisfactory' mask acceptance |
Perioperative.
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Postoperative pain.
기간: Up to 1 hour after surgery.
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Postoperative pain will be assessed using the Face, Legs, Activity, Cry and Consolability (FLACC) scale at post-anesthesia care unit arrival and every 0.25 hour for 1 hour after surgery. |
Up to 1 hour after surgery.
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Extubation time.
기간: End of surgery.
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At the end of surgery, the trachea will be extubated with the patient in the lateral position after confirmation that the gag reflex returned |
End of surgery.
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The total dose of rescue propofol.
기간: Up to 1 hour after surgery.
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Parental contact will be initiated as the first line management od delirium. If the PAED score remains at least 13 with a Delirium-specific score at least 9 despite parental contact, 1 mg/kg IV propofol will be administered. This dose will be repeated after 15 min if the child still agitated. |
Up to 1 hour after surgery.
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The total dose of rescue fentanyl.
기간: Up to 1 hour after surgery.
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A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl. This dose will be repeated after 15 min if the child still in pain. The total dose of rescue fentanyl will be recorded. |
Up to 1 hour after surgery.
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Anxiety scores.
기간: Perioperative.
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anxiety scores before the administration of the study drugs and during parent separation and during anesthesia induction will be assessed by the modified Yale preoperative anxiety scale-short form (m-YPAS-SF). |
Perioperative.
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Side effects.
기간: Up to 1 hour after surgery.
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Postoperative nausea and vomiting, bradycardia, hypotension, respiratory events will be recorded. |
Up to 1 hour after surgery.
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- 36265PR276/10/26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data will be available upon a reasonable request from the corresponding author.
IPD 공유 기간
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 공유 액세스 기준
The data will be available upon a reasonable request from the corresponding author.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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