Recruiting

Acetaminophen & Dexamethasone

Sponsor:

London Health Sciences Centre

Code:

NCT03323047

Conditions

Tonsillitis

Eligibility Criteria

Sex: All

Age: 3 - 13

Healthy Volunteers: Not accepted

Interventions

Acetaminophen

Low-dose Dexamethasone

Placebo Oral Tablet

High-Dose Dexamethasone

Study Details

Brief 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

Study ID

NCT03323047

Start date

Mar 1, 2018

Status verified date

Feb, 2021

Completion date

Sep, 2021

Anticipated

Primary completion date

May, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 13

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Healthy patients
  • aged 3-13 years
  • Level I or level II on the American Society of Anesthesiologists (ASA) physical status classification system (as determined by the anesthesiologist)
  • obstructive sleep apnea or recurrent throat infections
  • undergoing elective tonsillectomy with or without adenoidectomy
  • Parents who agree to complete documentation and follow up at 14 days post-operation.

Exclusion Criteria:

  • Patients Level III or greater on the American Society of Anesthesiologists (ASA) physical status classification system (as determined by the anesthesiologist)
  • Patients with chronic conditions that would limit our ability to develop the study according to objectives, such as neurodevelopmental conditions preventing patients from understanding the Oucher tool
  • Hepatic or renal disease
  • cardiac disease
  • active infection
  • diabetes mellitus
  • sickle cell disease
  • known coagulation disorders
  • pre- operative treatment with anti-emetics, steroids, or analgesics
  • Acetaminophen allergy or already receiving acetaminophen within 24 h of surgery
  • Complicating health factors precluding the use of opioids or acetaminophen
  • any other factors which would interfere with pain assessment and management
  • Patients weighing more than 30 kg that would exceed maximum dexamethasone dose
  • Patients who live without a home telephone
  • patient living without parental supervision.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group 1

Acetaminophen and High-dose dexamethasone: a single dose of oral acetaminophen (15 mg/kg) 1 hr pre-operatively and intravenous administration of high-dose dexamethasone (0.5 mg/kg, max. 10 mg) immediately after induction of anesthesia.

active comparator: Group 2

Acetaminophen and Low-dose Dexamethasone: a single dose of oral acetaminophen (15 mg/kg) 1 hr pre-operatively and intravenous administration of low-dose dexamethasone (0.15 mg/kg, max. 8 mg) immediately after induction of anesthesia

placebo comparator: Group 3

Placebo oral tablet and Low-dose Dexamethasone: an oral placebo given 1 hr pre-operatively and intravenous administration of low dose dexamethasone (0.15 mg/kg, max. 8 mg) immediately after induction of anesthesia.

Interventions

Acetaminophen

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

Low-dose Dexamethasone

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

Placebo Oral Tablet

Oral placebo 1 hr pre-operatively

High-Dose Dexamethasone

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

Primary outcome measure

  • Oucher pain score [ Time Frame: awakening from anesthesia (0.5 hours post- operation) ]

Central Contacts and Locations

Central contacts

Josee Paradis, MD

519.685.8794Josee.Paradis@lhsc.on.ca

Locations

Children's Hospital

Recruiting

London, Ontario, Canada

Contacts

Alexandria Houston

519-685-8500Alexandria.Houston@lhsc.on.ca

Principal Investigator:

Josee Paradis, MD

More Information

Sponsor

London Health Sciences Centre

Last update posted

Feb 18, 2021

Last verified

Feb, 2021

Keywords

  • tonsillectomy
  • acetaminophen
  • dexamethasone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre on 2021-02-18.