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Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in children 3-5 years old
Two group RCT comparing usual care (midazolam) and distraction (tablet) on preoperative anxiety, emergence delirium, sedation/agitation, and vomiting in preschool children 3-5 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | Usual care (midazolam) is administered pre-operatively |
|
| Distraction | Experimental | Distraction (interactive tablet) is given to children pre-operatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Distraction | Behavioral | Distraction (interactive tablet) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety" | Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale (mYPAS); scores range 23-100 with higher scores indicating greater levels of anxiety. A categorical variable was created using a cut-off score of 30 or more to indicate "anxiety" and scores of less than 30 indicated "no anxiety". | Pre-induction of mask anesthesia in the operating room |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation/Agitation | Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS) The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy M Albert, PhD | The Cleveland Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25040433 | Background | Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS Jr, Roth A, Rosenblatt A, Jesdale BM, Suresh S. Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Paediatr Anaesth. 2014 Dec;24(12):1217-23. doi: 10.1111/pan.12475. Epub 2014 Jul 17. | |
| 15114210 |
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Children ages 3-5 years were recruited from the pre-operative area at a single surgery site between April 2017 to March 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual care (midazolam) is administered pre-operatively Usual care: Anxiolytic ordered by anesthesiologist is usual care |
| FG001 | Distraction | Distraction (interactive tablet) is given to children pre-operatively Distraction: Distraction (interactive tablet) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data was not reported on participants lost to attrition
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual care (midazolam) is administered pre-operatively Usual care: Anxiolytic ordered by anesthesiologist is usual care |
| BG001 | Distraction | Distraction (interactive tablet) is given to children pre-operatively Distraction: Distraction (interactive tablet) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety" | Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale (mYPAS); scores range 23-100 with higher scores indicating greater levels of anxiety. A categorical variable was created using a cut-off score of 30 or more to indicate "anxiety" and scores of less than 30 indicated "no anxiety". | Posted | Count of Participants | Participants | Pre-induction of mask anesthesia in the operating room |
|
Time in study = time they received the intervention (control or experimental) until discharged from post anesthesia care unit. Each participant was in the study from 2-6 hours. Operating room times varied by surgical procedure.
Not applicable, no adverse events reported.
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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 | Usual Care | Usual care (midazolam) is administered pre-operatively Usual care: Anxiolytic ordered by anesthesiologist is usual care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Levay, Nurse Research Manager | Cleveland Clinic | 216-445-4749 | 54749 | levaym@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 26, 2018 | Mar 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 26, 2018 | Mar 26, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019857 | Osteogenesis, Distraction |
| ID | Term |
|---|---|
| D001852 | Bone Lengthening |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Group 1: usual care Group 2: distraction
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Not a blinded study
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| Usual care |
| Other |
Anxiolytic ordered by anesthesiologist is usual care |
|
|
| Pre-induction of mask anesthesia in the operating room |
| Number of Participants Experiencing Emergence Delirium | Postoperatively pediatric patients were assessed for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) tool. The scale uses a 5-point Likert scale with total scores ranging from 0 - 20. This study used a score of 12-20 to indicate the presence of "emergence delirium." | After surgery when patient woke up in the post anesthesia care unit (recovery room) |
| Sedation/Agitation | Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS) The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation". | After surgery at the time of admission to post anesthesia care unit (recovery room) |
| Length of Stay (Minutes) | Length of stay (total minutes) = time patient admitted to post anesthesia care unit (recovery room) until discharged from post anesthesia care unit. | Post operative until discharged from post anesthesia care unit (recovery room) |
| The Number of Patients Experiencing Postoperative Vomiting | The number of participants that vomited in the post-anesthesia care unit (from the time they were admitted until they were discharged). | After surgery in the post anesthesia care unit from admission to discharge |
| Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015. |
| 15562048 | Background | Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type of surgery | Count of Participants | Participants |
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| Secondary | Sedation/Agitation | Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS) The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation". | Posted | Count of Participants | Participants | Pre-induction of mask anesthesia in the operating room |
|
|
|
| Secondary | Number of Participants Experiencing Emergence Delirium | Postoperatively pediatric patients were assessed for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) tool. The scale uses a 5-point Likert scale with total scores ranging from 0 - 20. This study used a score of 12-20 to indicate the presence of "emergence delirium." | Posted | Count of Participants | Participants | After surgery when patient woke up in the post anesthesia care unit (recovery room) |
|
|
|
| Secondary | Sedation/Agitation | Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS) The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation". | Posted | Count of Participants | Participants | After surgery at the time of admission to post anesthesia care unit (recovery room) |
|
|
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| Secondary | Length of Stay (Minutes) | Length of stay (total minutes) = time patient admitted to post anesthesia care unit (recovery room) until discharged from post anesthesia care unit. | Posted | Mean | Inter-Quartile Range | Minutes | Post operative until discharged from post anesthesia care unit (recovery room) |
|
|
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| Secondary | The Number of Patients Experiencing Postoperative Vomiting | The number of participants that vomited in the post-anesthesia care unit (from the time they were admitted until they were discharged). | Posted | Count of Participants | Participants | After surgery in the post anesthesia care unit from admission to discharge |
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| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Distraction | Distraction (interactive tablet) is given to children pre-operatively Distraction: Distraction (interactive tablet) | 0 | 52 | 0 | 52 | 0 | 52 |
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| Agitated |
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| Agitated |
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