Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Mask acceptance
研究概览
简要总结
This study will enroll children ages 2-6 who are undergoing an elective outpatient surgical procedure under general anesthesia. They will be randomized to one of the following groups and assessed for preoperative anxiety, mask acceptance, and behavioral changes in the following week.
- darkened room and star projector with parental presence;
- preoperative midazolam 0.5 mg/kg by mouth and parental presence; or
- parental presence alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2 to 6 years old
- •American Society of Anesthesiologists physical status I-II
- •Outpatient elective surgical procedures
- •Undergoing general anesthesia
- •Parent or guardian willing to be present during induction
排除标准
- •History of previous surgery
- •Fear of the dark
- •Contraindication to inhalational mask induction of general anesthesia such as allergy to inhalation medication, NPO violation, active nausea or vomiting, severe GERD, etc.
- •Severe developmental delay
- •Severe obvious, preoperative anxiety
- •Patients currently using psychiatric medications
- •Non-English speaking
研究组 & 干预措施
Darkened room and star projector with parental presence
Subjects assigned to this arm, when in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on. They will also have a parent in the room with them during induction of anesthesia.
干预措施: Parental Presence (Other)
Darkened room and star projector with parental presence
Subjects assigned to this arm, when in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on. They will also have a parent in the room with them during induction of anesthesia.
干预措施: Dark with star projector (Other)
Preoperative midazolam 0.5 mg/kg po and parental presence
Subjects assigned to this arm will be given midazolam by mouth preoperatively, and will have a parent in the room with them during induction of anesthesia.
干预措施: Parental Presence (Other)
Parental presence alone
Subjects assigned to this arm will have a parent in the room with them during induction of anesthesia.
干预措施: Parental Presence (Other)
Preoperative midazolam 0.5 mg/kg po and parental presence
Subjects assigned to this arm will be given midazolam by mouth preoperatively, and will have a parent in the room with them during induction of anesthesia.
干预措施: Preoperative midazolam (Drug)
结局指标
主要结局
Mask acceptance
时间窗: during induction evaluated up until the start of the scheduled surgery
Mask acceptance during inhalational mask induction as measured by the mask acceptance scale (MAS). The MAS is scored on a scale from 1-4 by evaluating if the child is calm and accepting of the mask (4), slightly scared but easily calmed (3), has moderate fear of the mask and is not easily calmed (2), or cries, screams, or is terrified (1) during induction when using the inhalation mask. A higher score is better.
次要结局
- Perioperative anxiety(Measured preoperatively, then measured again during the entry to operating room.)
- Parental satisfaction of induction experience(evaluated after child's induction is complete up until the end of surgery)
- Post-Operative Emergency Delirium(from PACU arrival until discharge)
- Behavioral Changes(Day 1 Post-Op and Day 7 Post-Op, up to 30 days post-operatively)
- Time to PACU discharge(time in recovery, up to 30 days post-op)
研究者
Natalie Barnett
Associate Professor-Faculty
Medical University of South Carolina