PainNCT07770529
iPad for Post Operative Pain After Tonsillectomy
A study testing iPad in people with Pain, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Pain
- What is being tested?
- iPad
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 6 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) classified patients I-III
- Patients scheduled for tonsillectomy with or without adenoidectomy by Dr. Jeffrey Rastatter,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Peri-Operative Tablet-Based Interactive Distraction (TBID) to Minimize Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy/Adenotonsillectomy
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.
Read the 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.
- Conditions
- Pain
- Being tested
- iPad, Intervention Control
- Keywords
- tablet, ipad, interaction, pediatric, pain, emergence delirium, tonsillectomy
- Medical subject headings
- Pain, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPadDevice
Tablet Based Interactive Distraction (TBID) involves subjects either passively watching video content or actively engaging in video games on an iPad tablet.
Intervention ControlBehavioural
Subjects in control comparator group receive postoperative standard of care, per study protocol. No Tablet Based Interactive Distraction (TBID) is used.
| Study group | Role | What they receive |
|---|---|---|
| Tablet Based Interactive Distraction | Experimental | Subjects will be presented postoperatively with an iPad with loaded games and videos to the child at regular 2 minute intervals. If accepted and used, the subject will be allowed to use the iPad throughout the immediate and extended recovery periods. Receives: Device: iPad |
| Control - Standard of Care | Active comparator | Subjects randomized to the control group will not be offered an iPad during the post-operative period. Parents and caregivers will be asked not to provide any tablet based devices for the remainder of hospital admission. Receives: Behavioral: Intervention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the immediate post-operative period (30-60 minutes after surgery)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Survey completed at instance prior to discharge from the hospital (up to approximately 4 hours postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startJul 2015
- Primary completion6 Dec 2017
- Study completion6 Dec 2017
Why it stopped: PI left institution and study activity was not continued (enrollment not complete)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Seiden, M.D., Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770529
- Sponsor's protocol ID
- 2015-284
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2015
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Operative Tablet-Based Interactive Distraction (TBID) to Minimize Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy/Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT07770529
- Acronym / sponsor ID
- 2015-284
- Conditions
- Pain
- Keywords
- tablet, ipad, interaction, pediatric, pain, emergence delirium, tonsillectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution and study activity was not continued (enrollment not complete)
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet Based Interactive Distraction | Experimental | Device: iPadSubjects will be presented postoperatively with an iPad with loaded games and videos to the child at regular 2 minute intervals. If accepted and used, the subject will be allowed to use the iPad throughout the immediate and extended recovery periods. |
| Control - Standard of Care | Active comparator | Behavioral: Intervention ControlSubjects randomized to the control group will not be offered an iPad during the post-operative period. Parents and caregivers will be asked not to provide any tablet based devices for the remainder of hospital admission. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classified patients I-III
- Patients scheduled for tonsillectomy with or without adenoidectomy by Dr. Jeffrey Rastatter,
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPadTablet Based Interactive Distraction (TBID) involves subjects either passively watching video content or actively engaging in video games on an iPad tablet. | Device | Tablet Based Interactive Distraction |
| Intervention ControlSubjects in control comparator group receive postoperative standard of care, per study protocol. No Tablet Based Interactive Distraction (TBID) is used. | Behavioural | Control - Standard of Care |
Primary outcome
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.
4 secondary outcomes
Observer Reported Pain Scores on the CHEOPS scale
Time frame: During hospital admission (up to approximately 4 hours postoperatively)
Observer Reported Emergence Delirium one the PAED scale
Time frame: Within the immediate post-operative period (30-60 minutes after surgery)
Subject Reported Pain Scores on the FACES-R scale
Time frame: During hospital admission (up to approximately 4 hours postoperatively)
Parental Peri-Operative Satisfaction via Survey
Time frame: Survey completed at instance prior to discharge from the hospital (up to approximately 4 hours postoperatively)
Results and safety
The study was stopped early (reason given: PI left institution and study activity was not continued (enrollment not complete)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Seiden, M.D. principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPad in people with Pain, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left institution and study activity was not continued (enrollment not complete)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rescue IV Morphine (Medication administration via # of doses, total mg) (time frame: Within the immediate post-operative period (30-60 minutes after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.