Pain
Conditions
Keywords
tablet, ipad, interaction, pediatric, pain, emergence delirium, tonsillectomy
Brief summary
The purpose of this study is to determine the clinical effectiveness of presenting iPads (Tablet Based Interactive Distraction) to pediatric patients following tonsillectomies/adenotonsillectomies. This randomized controlled trial compares rescue analgesia administration, pain scores, emergence delirium scores, and perio-operative parental satisfaction between subjects either receiving or not receiving an iPad in the postoperative period.
Detailed description
The purpose of this study is to determine the clinical effectiveness of presenting iPads (Tablet Based Interactive Distraction) to pediatric patients following tonsillectomies/adenotonsillectomies. Previous studies have demonstrated that TBID is an effective tool for anesthesia induction for children by providing a form of distraction to stressful stimuli. This study aims to determine the efficacy of TBID during the postoperative period. This randomized controlled trial compares rescue analgesia administration, pain scores, emergence delirium scores, and perio-operative parental satisfaction between subjects either receiving or not receiving an iPad, while controlling pre- intra- and post-operative factors.
Interventions
DEVICEiPad
Tablet Based Interactive Distraction (TBID) involves subjects either passively watching video content or actively engaging in video games on an iPad tablet.
BEHAVIORALIntervention Control
Subjects in control comparator group receive postoperative standard of care, per study protocol. No Tablet Based Interactive Distraction (TBID) is used.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) classified patients I-III * Patients scheduled for tonsillectomy with or without adenoidectomy by Dr. Jeffrey Rastatter,
Exclusion criteria
* Having other procedures performed in addition (with the exception of ear tube insertions) * Patients scheduled for staying overnight * Diagnosis of Severe Obstructive Sleep Apnea * Diagnosis of psychiatric illness, physical or developmental delay which may confound pain assessment * Regular use of opioid medication * Need for postoperative mechanical ventilation * Non-English speaking parents and children
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rescue IV Morphine (Medication administration via # of doses, total mg) | Within the immediate post-operative period (30-60 minutes after surgery) | Total number of doses (0.05mg/kg) and cumulative morphine (mg) when subjects are in the post anesthesia care unit will be compared between groups. Rescue administration will be given when subjects meet study criteria and thresholds for treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observer Reported Pain Scores on the CHEOPS scale | During hospital admission (up to approximately 4 hours postoperatively) | Observer reported pain scores using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) will be recorded at regular time intervals during hospital admission following surgery. |
| Observer Reported Emergence Delirium one the PAED scale | Within the immediate post-operative period (30-60 minutes after surgery) | Observer reported emergence delirium scores using the Pediatric Emergence Delirium Scale will be recorded at regular time intervals when subjects are in the post anesthesia care unit. |
| Subject Reported Pain Scores on the FACES-R scale | During hospital admission (up to approximately 4 hours postoperatively) | Subject reported pain scores using the Faces Pain Scale - Revised will be recorded at regular time intervals when subjects are in the post anesthesia care unit. |
| Parental Peri-Operative Satisfaction via Survey | Survey completed at instance prior to discharge from the hospital (up to approximately 4 hours postoperatively) | Parents will report satisfaction with anesthetic care using the Pediatric Perianesthesia Questionnaire right before discharge from the hospital. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSamuel Seiden, M.D.
Ann & Robert H Lurie Children's Hospital of Chicago
Outcome results
None listed