Postoperative Pain After Pediatric Adenotonsillectomy With Ketorolac or Ibuprofen
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13-18
SponsorBaylor College of Medicine
About this trial
This prospective observational study will evaluate postoperative pain after outpatient pediatric adenotonsillectomy in adolescents prescribed either acetaminophen with ibuprofen or acetaminophen with oral ketorolac after discharge, based on the prescribing preference of the otolaryngology surgeon. Participants will complete text-message surveys after discharge to assess pain severity, medication administration, and functional recovery for up to 14 days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adolescents undergoing outpatient adenotonsillectomy at Texas Children's Hospital Main Campus.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Cohort 1: Acetaminophen + Ibuprofen
Group B: Cohort 2: Acetaminophen + Oral Ketorolac
Trial outcomes
Primary outcomes
1
Incidence of severe postoperative pain
Pain score measured using the 0-10 Numeric Rating Scale after adenotonsillectomy.
Time frame
Postoperative days 1, 3, 5, 7, 10Secondary outcomes
1
Incidence of severe postoperative pain
Proportion of participants reporting severe pain, defined as Numeric Rating Scale score 7-10.
Time frame
Postoperative days 1, 3, 5, 7, 10Other outcomes
1
Medication administration after discharge
Participant-reported completion, missed doses, or non-use of prescribed postoperative analgesics.
Time frame
Postoperative days 1, 3, 5, 7, 102
Emergency department or urgent care visit for pain
Proportion of participants presenting to the emergency department or urgent care for pain related to adenotonsillectomy.
Time frame
Postoperative days 1, 3, 5, 7, 10Sponsors and contacts
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Source ClinicalTrials.gov