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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Osama M Rehab, MD
- 电话号码:002 01095210806
- 邮箱:osamarehab@med.tanta.edu.eg
学习地点
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Gharbia Governorate
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Tanta、Gharbia Governorate、埃及、31527
- Tanta University Hospitals
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接触:
- Osama M Rehab, MD
- 电话号码:002 01095210806
- 邮箱:osamarehab@med.tanta.edu.eg
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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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实验性的: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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安慰剂比较: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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of negative behavioral changes at 24-h following surgery.
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of negative behavioral changes at 3, 7, 14, 30 days following surgery.
大体时间:Up to 1 month 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. |
Up to 1 month after surgery
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Incidence of emergence delirium.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 36265PR276/10/26
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
The data will be available upon a reasonable request from the corresponding author.
IPD 共享时间框架
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 共享访问标准
The data will be available upon a reasonable request from the corresponding author.
IPD 共享支持信息类型
- 研究方案
- 树液
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