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Perioperative Tonsillectomy Protocol Development

NCT03323047 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-02-18

No results posted yet for this study

Summary

Pediatric patients who are undergoing a tonsillectomy at the Children's hospital will be randomly assigned to one of three drug groups: 1) acetaminophen (Tylenol) administered pre-operatively and a low dose of anti-inflammatory drug (dexamethasone) administered intra-operatively; 2) acetaminophen (Tylenol) administered pre-operatively and a high dose of anti-inflammatory drug (dexamethasone) administered intra-operatively; 3) no acetaminophen (Tylenol) administered pre-operatively, low dose anti-inflammatory (dexamethasone) administered intra-operatively. The present study will evaluate differences in pain management and surgical complications across the three groups of drug regimens. Main study outcomes include: pain medication administration during surgery, use of pain killers at 1-week post-operation, subjective pain scores administered in the post-anesthesia care unit (PACU) and 1 week postoperation, fluid and food intake, and complication rates (i.e. postoperative bleed rate). The hypothesis is that pain will be lowest in the group that received Tylenol and high-dose dexamethasone (Group 2).

Conditions

  • Tonsillitis

Interventions

DRUG

Acetaminophen

Oral acetaminophen (15 mg/kg) 1 hr pre-operatively

DRUG

Low-dose Dexamethasone

Intravenous low-dose dexamethasone (0.15 mg/kg, max. 8 mg) immediately after induction of anesthesia

DRUG

Placebo Oral Tablet

Oral placebo 1 hr pre-operatively

DRUG

High-Dose Dexamethasone

Intravenous high-dose dexamethasone (0.5 mg/kg, max. 10 mg) immediately after induction of anesthesia

Sponsors & Collaborators

  • London Health Sciences Centre

    lead OTHER

Principal Investigators

  • Josee Paradis, MD · LHSC

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2021-05-31
Completion
2021-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03323047 on ClinicalTrials.gov