Skip to main content
OpenTrials
Terminated

NCT Number: NCT07770529

iPad for Post Operative Pain After Tonsillectomy

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.

Why the study stopped: PI left institution and study activity was not continued (enrollment not complete)
Terminated

Looking for future studies?

Notify Me

Key information

Conditions

Pain Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iPad

Device

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

Intervention Control

Behavioral

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Observer Reported Pain Scores on the CHEOPS scale

    Time frame: 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.

  2. Observer Reported Emergence Delirium one the PAED scale

    Time frame: 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.

  3. Subject Reported Pain Scores on the FACES-R scale

    Time frame: 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.

  4. Parental Peri-Operative Satisfaction via Survey

    Time frame: 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.

Other outcomes

  1. Observer Reported Preoperative Anxiety on the my-PAS scale

    Time frame: Measurements taken in preoperative waiting area, at separation, and anesthesia induction on the day of surgery, prior to anesthesia.

    Observer reported anxiety of subjects using the modified yale preoperative anxiety scale and induction compliance checklist will be recorded at three preoperative time points (baseline resting, separation from parent, induction of anesthesia), on the day of surgery prior to anesthesia. .

  2. Parent Reported Child Temperament via Survey

    Time frame: Survey will be completed on the day of surgery, prior to anesthesia.

    Parents will complete the Emotionality, Activity, Sociability, and Impulsivity Temperament Survey, describing their child's behavior prior to surgery.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

Peri-Operative Tablet-Based Interactive Distraction (TBID) to Minimize Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy/Adenotonsillectomy

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.