Perioperative Tonsillectomy Protocol Development

NCT03323047 | Unknown Phase 4

• 1 other identifier: 109757
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

tonsillectomy; acetaminophen; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Oucher pain score

  pain intensity on the Oucher pain tool, which includes ratings by face scale and a number scale (0-10).

  awakening from anesthesia (0.5 hours post- operation)

Secondary Outcomes (8)

• Analgesia use

  during operation

• time to first oral fluid intake

  during patient's stay in PACU (on average 5 hours)

• time to first request for morphine

  during patient's stay in PACU (on average 5 hours)

• dose of morphine required

  from end of operation to 7 days post-operation

• vomiting

  From end of operation to 7 days post-operation

Study Arms (3)

Group 1

EXPERIMENTAL

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.

Drug: Acetaminophen; Drug: High-Dose Dexamethasone

Group 2

ACTIVE COMPARATOR

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

Drug: Acetaminophen; Drug: Low-dose Dexamethasone

Group 3

PLACEBO COMPARATOR

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.

Drug: Low-dose Dexamethasone; Drug: Placebo Oral Tablet

Interventions

Acetaminophen DRUG

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

Also known as: Tylenol

Group 1; Group 2

Low-dose Dexamethasone DRUG

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

Also known as: Dexamethasone sodium phosphate

Group 2; Group 3

Placebo Oral Tablet DRUG

Oral placebo 1 hr pre-operatively

Also known as: Placebo

Group 3

High-Dose Dexamethasone DRUG

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

Also known as: Dexamethasone sodium phosphate

Group 1

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre: lead

Study Sites (1)

Children's Hospital

London, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Tonsillitis

Interventions

Acetaminophen; Dexamethasone; dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Josee Paradis, MD

  LHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josee Paradis, MD

CONTACT

519.685.8794; Josee.Paradis@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will blinded to the group that they have been allocated to. Blinding will be possible as all patients will be given either acetaminophen or medication without active ingredients (placebo pilll) and dexamethasone will be administered while the participant is asleep. Participants will be debriefed on which group they were assigned to after all study material is returned (i.e., at their post-operative follow-up appointment).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paediatric Otolaryngologist Assistant Professor - Department of Otolaryngology-Head and Neck Surgery

Model Details: A prospective, randomized, longitudinal, double-blinded trial at a single centre with 3 groups of 20 children each. Group 1 receives acetaminophen (15 mg/kg) 30 min-1 hr pre-operatively and high-dose dexamethasone (0.5 mg/kg, max. 10 mg) immediately after induction of anesthesia. Group 2 receives acetaminophen (15 mg/kg) 30 min- 1 hr pre-operatively and low-dose dexamethasone (0.15 mg/kg, max. 8 mg) immediately after induction of anesthesia. Group 3 receives placebo 1 hr pre-operatively and low dose dexamethasone (0.15 mg/kg, max. 8 mg) immediately after induction of anesthesia. We will recruit a convenience sample of 60 patients aged 3-13 scheduled for tonsillectomy with the principal investigator or co-investigators. The patients will be placed in one of the groups by a computerized randomization table.

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 26, 2017
• Study Start: March 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)