Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery: A-Comparative Randomized Double Blind Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- evaluate sedative effects of oral, or nebulized ketamine in preschoolers undergoing elective surgery
研究概览
简要总结
the primary objective of this study is to investigate the sedative, and analgesic effects of oral, or nebulized ketamine as premedication drugs, and providing postoperative analgesia for the preschoolers and decrease their need for systemic analgesia.The secondary objective is to compare each sedation technique after oral, or nebulized ketamine for safety ,and procedural outcomes.
详细描述
Preoperative communication, premedication interventions, and being accompanied by parents are useful methods in decreasing preoperative separation anxiety , postoperative psychological trauma, and ensuring smooth induction for preschoolers undergoing elective surgery.
Procedural sedation, and analgesia was defined by O'Donnell as a drug induced state of decreasing awareness, pain, and memory that allowing patient continue his ,or her own protective reflexes, and moving purposefully( O' Donnell etal, 2003).
Ketamine is an anesthetic drug having sedative, and analgesic properties with different routes of administration in children (IV, intramuscular, subcutaneous, oral, rectal, sublingual, intranasal, and nebulized) .
Ketamine produces its analgesic properties in acut pain management from reversible antagonizing the N-methyl-D-aspartate (NMDA)receptors , reducing levels of many proinflammatory mediators in the acute phase, and acting on other non-NMDA pathways that playing important roles in pain, and mood regulation, like its effect on µ-opioid receptors, nicotinic, muscarinic cholinergic, ɣ-aminobutyric acid receptors, activation of high -affinity D2 dopamine receptors, and L-type voltage-gated calcium channels.
The oral route is the most popular than other routes ,as it's safe, efficient, acceptable, and familiar for pediatric patients..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The investigator will prepare the drug, and the out come assessor(the anesthesiologist not sharing in the study) will assess the primary, and secondary outcomes
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents acceptance.
- •Age (3-6) years old.
- •American Society of Anesthesiologist physical status (ASA) I / II
- •Elective surgery of approximately half to one hour duration under general anesthesia.
- •Child With Body Mass Index (BMI) (15-18kg/m²)
排除标准
- •Parents refusal.
- •Altered mental status, and epilepsy.
- •History of allergy to ketamine.
- •Recent respiratory tract infection.
- •Sever dysfunction of the central nervous system.
- •Increased intracranial pressure, and increased intra-ocular pressure.
- •Cardiac dysrhythmia ,and/or congenital heart disease.
研究组 & 干预措施
oral ketamine
evaluate sedative,and analgesic effects
干预措施: Ketamine (Drug)
nebulized ketamine
evaluate sedative, and analgesic effects
干预措施: Ketamine (Drug)
结局指标
主要结局
evaluate sedative effects of oral, or nebulized ketamine in preschoolers undergoing elective surgery
时间窗: 30 minutes.
• To assess onset time of sedation by sedation scale (SS-5) score. The sedation scale: 1. Rarely awake, needs shaking, or shouting to wake up. 2. Asleep, eyes closed, wake up when called softly,or lightly touched. 3. Sleepy, but eyes open spontaneously. 4. Awake. 5. Agitated.
compare each sedation technique for the time of separation state.
时间窗: at 30 minutes after drug intake
The separation state will be assessed and designated as satisfactory separation if the Emotional State Scale (ESS-4) score will be no more than two points. The Emotional State Scale (ESS-4): 1. Calm. 2. Apprehensive, not smiling, tentative behavior, withdrawn. 3. Crying. 4. Thrashing, crying with movements of the arms, and legs, resisting.
compare the sedation technique for successful venous cannulation.
时间窗: at time of attempted cannulation, regardless of whether the vein is actually cannulated on the first attempt.
Successful venous cannulation is defined as an Emotional State Scale (ESS-4≤ 2). The Emotional State Scale (ESS-4): 1. Calm. 2. Apprehensive, not smiling, tentative behavior, withdrawn. 3. Crying. 4. Thrashing, crying with movements of the arms, and legs, resisting.
次要结局
- to compare the intensity of pain postoperative.(immediately after recovery, and every half hour for four hours postoperative)
研究者
Alshaimaa Abdel Fattah Kamel
Principal investigator
Zagazig University