The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
241
This group will receive the standard preoperative visit to the hospital with Child Life intervention
0.5 mg/kg oral midazolam
One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction is completed. These parents will have completed a parent preparation program.
Yale University Department of Anesthesiology
New Haven, Connecticut, United States
Modified Yale Preoperative Anxiety Scale
The Modified Yale Preoperative Anxiety Scale (mYPAS) is the current "criterion standard" for assessing child anxiety during induction of anesthesia and has been used in \>100 studies. This observational instrument covers 5 items and is typically administered at 4 perioperative time points. Minimum value is 23.33 and maximum value is 100. Scores below 30 are considered low anxiety. Score of 30 or more is considered high anxiety.
Time frame: Day of surgery
Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0)
A total score is the number of categories checked (1-10). A perfect induction is when a patient does not exhibit negative behaviors, fear, or anxiety. A perfect score would be 0. icc 1 = Crying, tears in eyes icc 2 = Turns head away from mask icc 3 = Verbal refusal, says "no" icc 4 = Verbalization indicating fear or worry, "Where's mommy?" or "Will it hurt?" icc 5 = Pushes mask away with hands, pushes nurse/anesthesiologist with hands/feet icc 6 = Covers mouth/nose with hands/arms or buries face icc 7 = Hysterical crying, may scream icc8 = Kicks/flails legs/arms, arches back, and/or general struggling icc9 = Requires physical restraint icc10 = Complete passivity either rigid or limp icc 0 = Perfect induction
Time frame: Induction, up to 10 minutes
Percent of Children Crying During Induction
Children who were crying/ had tears in their eyes during induction.
Time frame: Induction, up to 10 minutes
Percentage of Children Arriving to PACU Awake
Whether child arrived to PACU awake Emergence of 1 // whether child arrived to PACU awake
Time frame: Arrival at PACU, after surgery up to 20 minutes
Percentage of Children Arriving to PACU in Deep Sleep
Whether child arrived to PACU awake Emergence of 2 // whether child arrived to PACU in deep sleep
Time frame: Arrival at PACU, after surgery up to 20 minutes
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Subjects in this group will receive both interventions 2 and 3.
Post Anesthesia Care Unit (PACU) IV Fluid
Total IV fluid per kg in PACU
Time frame: Post Anesthesia Care Unit up to 2 hours
Visual Analogue Pain Scale (VAS) 24 Hour After Surgery
Parent-ranted child pain on the Visual Analogue Scale. The VAS for pain is a unidimensional measure of pain presented in a horizontal line from 0-100. A higher score indicates greater pain intensity. 0-4= no pain/anxiety, 5-44= mild pain/anxiety, 45-74 = moderate pain/anxiety, 75-100 = severe pain/anxiety.
Time frame: 24 Hours after surgery
Heart Rate in the General Clinical Research Unit (GCRC)
Heart rate was measured in the GCRC by the nurse hours 0 through 6 after Surgery
Time frame: Hour 0-6 after surgery