iPad for Post Operative Pain After Tonsillectomy

Ann & Robert H Lurie Children's Hospital of Chicago40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Pain

Interventions

iPadDEVICE

Tablet Based Interactive Distraction (TBID) involves subjects either passively watching video content or actively engaging in video games on an iPad tablet.

Intervention ControlBEHAVIORAL

Subjects in control comparator group receive postoperative standard of care, per study protocol. No Tablet Based Interactive Distraction (TBID) is used.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Ann & Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Rescue IV Morphine (Medication administration via # of doses, total mg)

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.

Time frame: Within the immediate post-operative period (30-60 minutes after surgery)

Secondary Outcomes

Observer Reported Pain Scores on the CHEOPS scale

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.

Time frame: During hospital admission (up to approximately 4 hours postoperatively)

Observer Reported Emergence Delirium one the PAED scale

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.

Time frame: Within the immediate post-operative period (30-60 minutes after surgery)

Subject Reported Pain Scores on the FACES-R scale

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.

Time frame: During hospital admission (up to approximately 4 hours postoperatively)

Parental Peri-Operative Satisfaction via Survey

Parents will report satisfaction with anesthetic care using the Pediatric Perianesthesia Questionnaire right before discharge from the hospital.

Time frame: Survey completed at instance prior to discharge from the hospital (up to approximately 4 hours postoperatively)

Data from ClinicalTrials.gov

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