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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD037007-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
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| 3 | Active Comparator |
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| 4 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Preparation Program (Child Life Specialist) | Behavioral | This group will receive the standard preoperative visit to the hospital with Child Life intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Induction, up to 10 minutes |
| Percent of Children Crying During Induction | Children who were crying/ had tears in their eyes during induction. | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeev N Kain, MD, MBA | Yale University Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University Department of Anesthesiology | New Haven | Connecticut | 06510 | United States |
All enrolled participants were assigned to one of the four groups.
Recruitment occurred between 2003 and 2009 at the Yale Children's Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Preoperative Preparation Program (Child Life Specialist) : This group will receive the standard preoperative visit to the hospital with Child Life intervention |
| FG001 | Pre-medication |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Midazolam | Drug | 0.5 mg/kg oral midazolam |
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| Parental Presence during Induction of Anesthesia | Behavioral | 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. |
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| PPIA preparation program PLUS Midazolam premedication | Other | Subjects in this group will receive both interventions 2 and 3. |
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| Arrival at PACU, after surgery up to 20 minutes |
| Post Anesthesia Care Unit (PACU) IV Fluid | Total IV fluid per kg in PACU | 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. | 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 | Hour 0-6 after surgery |
Midazolam : 0.5 mg/kg oral midazolam
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Preoperative Preparation Program (Child Life Specialist) : This group will receive the standard preoperative visit to the hospital with Child Life intervention |
| BG001 | Pre-medication | Midazolam : 0.5 mg/kg oral midazolam |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Score on mYPAS scale | Day of surgery |
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| 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 | The discrepancy noted in the analysis population is due to missing data. | Posted | Number | Percentage of Participants | Induction, up to 10 minutes |
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| Primary | Percent of Children Crying During Induction | Children who were crying/ had tears in their eyes during induction. | The discrepancy noted in the analysis population is due to missing data | Posted | Number | Percentage of Participants | Induction, up to 10 minutes |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Children Arriving to PACU Awake | Whether child arrived to PACU awake Emergence of 1 // whether child arrived to PACU awake | The discrepancy noted in the analysis population is due to missing data | Posted | Number | Percentage of participants | Arrival at PACU, after surgery up to 20 minutes |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | The discrepancy noted in the analysis population is due to missing data | Posted | Number | Percentage of Participants | Arrival at PACU, after surgery up to 20 minutes |
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| Primary | Post Anesthesia Care Unit (PACU) IV Fluid | Total IV fluid per kg in PACU | The discrepancy noted in the analysis population is due to missing data | Posted | Mean | Standard Deviation | mL/Kg | Post Anesthesia Care Unit up to 2 hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | The discrepancy noted in the analysis population is due to missing data | Posted | Mean | Standard Deviation | Score on Visual Analogue Scale | 24 Hours after surgery |
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| 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 | The discrepancy noted in the analysis population is due to missing data | Posted | Mean | Standard Deviation | beats per minute | Hour 0-6 after surgery |
|
2-Weeks
Use of standard questionnaires
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | Preoperative Preparation Program (Child Life Specialist) : This group will receive the standard preoperative visit to the hospital with Child Life intervention | 0 | 61 | 0 | 61 | 0 | 61 |
| EG001 | Pre-medication | Midazolam : 0.5 mg/kg oral midazolam | 0 | 68 | 0 | 68 | 0 | 68 |
| EG002 | 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. | 0 | 54 | 0 | 54 | 0 | 54 |
| EG003 | 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. | 0 | 58 | 0 | 58 | 0 | 58 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zeev Kain | University of California, Irvine | 714-480-0039 | zkain@uci.edu |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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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. |
| OG003 | 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. |
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PPIA preparation program PLUS Midazolam premedication : Subjects in this group will receive both interventions 2 and 3.
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PPIA preparation program PLUS Midazolam premedication : Subjects in this group will receive both interventions 2 and 3.
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| OG003 |
| 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. |
|
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PPIA preparation program PLUS Midazolam premedication : Subjects in this group will receive both interventions 2 and 3.
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