NCT07574476

Brief Summary

This is a prospective, observational study to determine the association between preoperative fasting duration and post-tonsillectomy pain scores in the post-anesthesia care unit (PACU) among pediatric patients undergoing tonsillectomy with or without adenoidectomy and/or tympanostomy tube placement. The primary outcome is the post-tonsillectomy pain score, with the secondary outcomes as total postoperative opioid consumption, PACU length of stay, and hospital length of stay.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

2.9 years

First QC Date

April 27, 2026

Last Update Submit

May 5, 2026

Conditions

Tonsillar Disorder

Outcome Measures

Primary Outcomes (1)

  • Post-tonsillectomy pain scores

    Pain scores will be assessed in the post-anesthesia care unit (PACU) and on the inpatient floor (if admitted) every 15 minutes - 4 hours for the duration of their recovery until hospital discharge. The patient is asked to rate their pain on a scale of 0-10 with 0 being no pain and 10 being worst pain imaginable.

    2 - 24 hours post-op

Secondary Outcomes (3)

  • Postoperative opioid consumption

    2 - 24 hours post-op

  • PACU length of stay

    1 - 2 hours post-op

  • Hospital length of stay

    4 - 24 hours

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients undergoing tonsillectomy surgery

You may qualify if:

  • undergoing elective tonsillectomy with or without adenoidectomy and/or tympanostomy tube placement

You may not qualify if:

  • non-elective or urgent procedures
  • inpatient admission prior to surgery; patients with any missing required data
  • patients with conditions requiring deviation from standard anesthetic management (as determined by the anesthesiologist)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Research, Department of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 8, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations

US(1)