Psychological Influences on Postoperative Recovery
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 241
- Locations
- 1
- Primary Endpoint
- Percentage of Children Arriving to PACU Awake
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Outpatient tonsillectomy or tonsils/adenoids
- •ASA I, II
Exclusion Criteria
- •Developmental delay
- •ASA III-IV
- •Psychotropic medication
- •Meds which interfere with metabolism of midazolam
- •36 weeks gestation
Arms & Interventions
1
Intervention: Preoperative Preparation Program (Child Life Specialist) (Behavioral)
2
Intervention: Midazolam (Drug)
3
Intervention: Parental Presence during Induction of Anesthesia (Behavioral)
4
Intervention: PPIA preparation program PLUS Midazolam premedication (Other)
Outcomes
Primary Outcomes
Percentage of Children Arriving to PACU Awake
Time Frame: Arrival at PACU, after surgery up to 20 minutes
Whether child arrived to PACU awake Emergence of 1 // whether child arrived to PACU awake
Percentage of Children Arriving to PACU in Deep Sleep
Time Frame: Arrival at PACU, after surgery up to 20 minutes
Whether child arrived to PACU awake Emergence of 2 // whether child arrived to PACU in deep sleep
Heart Rate in the General Clinical Research Unit (GCRC)
Time Frame: Hour 0-6 after surgery
Heart rate was measured in the GCRC by the nurse hours 0 through 6 after Surgery
Modified Yale Preoperative Anxiety Scale
Time Frame: Day of surgery
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.
Visual Analogue Pain Scale (VAS) 24 Hour After Surgery
Time Frame: 24 Hours 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.
Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0)
Time Frame: Induction, up to 10 minutes
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
Percent of Children Crying During Induction
Time Frame: Induction, up to 10 minutes
Children who were crying/ had tears in their eyes during induction.
Post Anesthesia Care Unit (PACU) IV Fluid
Time Frame: Post Anesthesia Care Unit up to 2 hours
Total IV fluid per kg in PACU
Secondary Outcomes
No secondary outcomes reported
Investigators
Zeev Kain
Professor
University of California, Irvine