Adenoidectomy, Care, Postoperative, Otorhinolaryngologic Surgical Procedures, Pain, Postoperative, Surgical Procedures, Operative, Tonsillectomy
Conditions
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.
Interventions
BEHAVIORALPreoperative Preparation Program (Child Life Specialist)
This group will receive the standard preoperative visit to the hospital with Child Life intervention
DRUGMidazolam
0.5 mg/kg oral midazolam
BEHAVIORALParental Presence during Induction of Anesthesia
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.
OTHERPPIA preparation program PLUS Midazolam premedication
Subjects in this group will receive both interventions 2 and 3.
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Yale Preoperative Anxiety Scale | 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. |
| Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0) | 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 | Induction, up to 10 minutes | Children who were crying/ had tears in their eyes during induction. |
| Percentage of Children Arriving to PACU Awake | 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 | 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 |
| Post Anesthesia Care Unit (PACU) IV Fluid | Post Anesthesia Care Unit up to 2 hours | Total IV fluid per kg in PACU |
| Visual Analogue Pain Scale (VAS) 24 Hour After Surgery | 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. |
| Heart Rate in the General Clinical Research Unit (GCRC) | Hour 0-6 after surgery | Heart rate was measured in the GCRC by the nurse hours 0 through 6 after Surgery |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between 2003 and 2009 at the Yale Children's Hospital.
Pre-assignment details
All enrolled participants were assigned to one of the four groups.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Preoperative Preparation Program (Child Life Specialist) : This group will receive the standard preoperative visit to the hospital with Child Life intervention | 57 |
| Pre-medication Midazolam : 0.5 mg/kg oral midazolam | 66 |
| Parental Presence During Induction of Anesthesia Parental Presence during Induction of Anesthesia : 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. | 54 |
| Parental Presence During Induction of Anesthesia PLUS Premedic PPIA preparation program PLUS Midazolam premedication : Subjects in this group will receive both interventions 2 and 3. | 56 |
| Total | 233 |
Baseline characteristics
| Characteristic | Standard of Care | Pre-medication | Parental Presence During Induction of Anesthesia | Parental Presence During Induction of Anesthesia PLUS Premedic | Total |
|---|---|---|---|---|---|
| Age, Continuous | 6.59 Years STANDARD_DEVIATION 2.578 | 7.56 Years STANDARD_DEVIATION 6.48 | 6.57 Years STANDARD_DEVIATION 2.57 | 6.74 Years STANDARD_DEVIATION 2.5 | 6.96 Years STANDARD_DEVIATION 4.14 |
| Sex: Female, Male Female | 25 Participants | 38 Participants | 31 Participants | 33 Participants | 127 Participants |
| Sex: Female, Male Male | 32 Participants | 28 Participants | 23 Participants | 23 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 68 | 0 / 54 | 0 / 58 |
| other Total, other adverse events | 0 / 61 | 0 / 68 | 0 / 54 | 0 / 58 |
| serious Total, serious adverse events | 0 / 61 | 0 / 68 | 0 / 54 | 0 / 58 |
Outcome results
Primary
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
Population: The discrepancy noted in the analysis population is due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Heart Rate in the General Clinical Research Unit (GCRC) | 96.75 beats per minute | Standard Deviation 17.99 |
| Pre-medication | Heart Rate in the General Clinical Research Unit (GCRC) | 95.13 beats per minute | Standard Deviation 18.96 |
| Parental Presence During Induction of Anesthesia | Heart Rate in the General Clinical Research Unit (GCRC) | 97.39 beats per minute | Standard Deviation 18.32 |
| Parental Presence During Induction of Anesthesia PLUS Premedic | Heart Rate in the General Clinical Research Unit (GCRC) | 104.55 beats per minute | Standard Deviation 18.45 |
p-value: 0.04ANOVA
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Modified Yale Preoperative Anxiety Scale | 41.59 Score on mYPAS scale | Standard Deviation 22.18 |
| Pre-medication | Modified Yale Preoperative Anxiety Scale | 37.44 Score on mYPAS scale | Standard Deviation 21.8 |
| Parental Presence During Induction of Anesthesia | Modified Yale Preoperative Anxiety Scale | 46.17 Score on mYPAS scale | Standard Deviation 24.1 |
| Parental Presence During Induction of Anesthesia PLUS Premedic | Modified Yale Preoperative Anxiety Scale | 33.65 Score on mYPAS scale | Standard Deviation 15.23 |
p-value: 0.02ANOVA
Primary
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
Population: The discrepancy noted in the analysis population is due to missing data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Percentage of Children Arriving to PACU Awake | 55 Percentage of participants |
| Pre-medication | Percentage of Children Arriving to PACU Awake | 32 Percentage of participants |
| Parental Presence During Induction of Anesthesia | Percentage of Children Arriving to PACU Awake | 32 Percentage of participants |
| Parental Presence During Induction of Anesthesia PLUS Premedic | Percentage of Children Arriving to PACU Awake | 33 Percentage of participants |
p-value: 0.01Chi-squared
Primary
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
Population: The discrepancy noted in the analysis population is due to missing data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Percentage of Children Arriving to PACU in Deep Sleep | 45 Percentage of Participants |
| Pre-medication | Percentage of Children Arriving to PACU in Deep Sleep | 68 Percentage of Participants |
| Parental Presence During Induction of Anesthesia | Percentage of Children Arriving to PACU in Deep Sleep | 46 Percentage of Participants |
| Parental Presence During Induction of Anesthesia PLUS Premedic | Percentage of Children Arriving to PACU in Deep Sleep | 67 Percentage of Participants |
p-value: 0.01Chi-squared
Primary
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
Population: The discrepancy noted in the analysis population is due to missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0) | 68 Percentage of Participants |
| Pre-medication | Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0) | 83 Percentage of Participants |
| Parental Presence During Induction of Anesthesia | Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0) | 62 Percentage of Participants |
| Parental Presence During Induction of Anesthesia PLUS Premedic | Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0) | 86 Percentage of Participants |
Primary
Percent of Children Crying During Induction
Children who were crying/ had tears in their eyes during induction.
Time frame: Induction, up to 10 minutes
Population: The discrepancy noted in the analysis population is due to missing data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Percent of Children Crying During Induction | 32 Percentage of Participants |
| Pre-medication | Percent of Children Crying During Induction | 17 Percentage of Participants |
| Parental Presence During Induction of Anesthesia | Percent of Children Crying During Induction | 38 Percentage of Participants |
| Parental Presence During Induction of Anesthesia PLUS Premedic | Percent of Children Crying During Induction | 14 Percentage of Participants |
p-value: 0.01Chi-squared
Primary
Post Anesthesia Care Unit (PACU) IV Fluid
Total IV fluid per kg in PACU
Time frame: Post Anesthesia Care Unit up to 2 hours
Population: The discrepancy noted in the analysis population is due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Post Anesthesia Care Unit (PACU) IV Fluid | 13.18 mL/Kg | Standard Deviation 8.39 |
| Pre-medication | Post Anesthesia Care Unit (PACU) IV Fluid | 16.85 mL/Kg | Standard Deviation 9.76 |
| Parental Presence During Induction of Anesthesia | Post Anesthesia Care Unit (PACU) IV Fluid | 18.78 mL/Kg | Standard Deviation 11.44 |
| Parental Presence During Induction of Anesthesia PLUS Premedic | Post Anesthesia Care Unit (PACU) IV Fluid | 22.21 mL/Kg | Standard Deviation 14.8 |
p-value: 0.02ANOVA
Primary
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
Population: The discrepancy noted in the analysis population is due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Visual Analogue Pain Scale (VAS) 24 Hour After Surgery | 34.13 Score on Visual Analogue Scale | Standard Deviation 21.98 |
| Pre-medication | Visual Analogue Pain Scale (VAS) 24 Hour After Surgery | 35.93 Score on Visual Analogue Scale | Standard Deviation 23.35 |
| Parental Presence During Induction of Anesthesia | Visual Analogue Pain Scale (VAS) 24 Hour After Surgery | 38.30 Score on Visual Analogue Scale | Standard Deviation 24.3 |
| Parental Presence During Induction of Anesthesia PLUS Premedic | Visual Analogue Pain Scale (VAS) 24 Hour After Surgery | 47.02 Score on Visual Analogue Scale | Standard Deviation 24.53 |
p-value: 0.04ANOVA