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Perioperative Tonsillectomy Protocol Development

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ClinicalTrials.gov Identifier: NCT03323047
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Josee Paradis, London Health Sciences Centre

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).

Condition or disease Intervention/treatment Phase
Tonsillitis Drug: Acetaminophen Drug: Low-dose Dexamethasone Drug: Placebo Oral Tablet Drug: High-Dose Dexamethasone Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: 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).
Primary Purpose: Supportive Care
Official Title: Perioperative Tonsillectomy Protocol Development for Preoperative Acetaminophen and Intraoperative High Dose Dexamethasone: a Randomized Control Trial
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
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.
Drug: Acetaminophen
Oral acetaminophen (15 mg/kg) 1 hr pre-operatively
Other Name: Tylenol

Drug: High-Dose Dexamethasone
Intravenous high-dose dexamethasone (0.5 mg/kg, max. 10 mg) immediately after induction of anesthesia
Other Name: Dexamethasone sodium phosphate

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
Drug: Acetaminophen
Oral acetaminophen (15 mg/kg) 1 hr pre-operatively
Other Name: Tylenol

Drug: Low-dose Dexamethasone
Intravenous low-dose dexamethasone (0.15 mg/kg, max. 8 mg) immediately after induction of anesthesia
Other Name: Dexamethasone sodium phosphate

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.
Drug: Low-dose Dexamethasone
Intravenous low-dose dexamethasone (0.15 mg/kg, max. 8 mg) immediately after induction of anesthesia
Other Name: Dexamethasone sodium phosphate

Drug: Placebo Oral Tablet
Oral placebo 1 hr pre-operatively
Other Name: Placebo




Primary Outcome Measures :
  1. Oucher pain score [ Time Frame: awakening from anesthesia (0.5 hours post- operation) ]
    pain intensity on the Oucher pain tool, which includes ratings by face scale and a number scale (0-10).


Secondary Outcome Measures :
  1. Analgesia use [ Time Frame: during operation ]
    Whether or not intraoperative analgesia was required

  2. time to first oral fluid intake [ Time Frame: during patient's stay in PACU (on average 5 hours) ]
    amount of time that elapses before patient has a fluid intake

  3. time to first request for morphine [ Time Frame: during patient's stay in PACU (on average 5 hours) ]
    the time that elapses before patient requests morphine (if applicable)

  4. dose of morphine required [ Time Frame: from end of operation to 7 days post-operation ]
    if morphine administered, frequency, dosage and total amount of morphine patient took post-operatively

  5. vomiting [ Time Frame: From end of operation to 7 days post-operation ]
    Number of times patient vomited after surgery

  6. Pediatric Quality of Life Inventory [ Time Frame: Upon discharge (on average 5 hours post-operation), and 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days post-operation ]
    Validated post-tonsillectomy Quality of life questionnaire with Likert-scale questions regarding common post-operative symptoms

  7. Medication log [ Time Frame: discharge (on average 5 hours post-operation) to 7 days post-operation ]
    Record of pain medications (over the counter and prescription) patient as taken post-discharge from hospital

  8. Oucher pain score [ Time Frame: transfer to step-down care (1 hour post-operation), 3 hours post-operation, 5 hours post-operation, upon discharge, as well as 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days post-operation ]
    pain intensity on the Oucher pain tool, which includes ratings by face scale and a number scale (0-10).



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Ages Eligible for Study:   3 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323047


Contacts
Contact: Josee Paradis, MD 519.685.8794 Josee.Paradis@lhsc.on.ca

Locations
Canada, Ontario
Children's Hospital Recruiting
London, Ontario, Canada
Contact: Alexandria Houston    519-685-8500 ext 57125    Alexandria.Houston@lhsc.on.ca   
Principal Investigator: Josee Paradis, MD         
Sub-Investigator: Julie Strychowsky, MD         
Sub-Investigator: Murad Husein, MD         
Sponsors and Collaborators
London Health Sciences Centre
Investigators
Principal Investigator: Josee Paradis, MD LHSC

Responsible Party: Dr. Josee Paradis, Paediatric Otolaryngologist Assistant Professor - Department of Otolaryngology-Head and Neck Surgery, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03323047     History of Changes
Other Study ID Numbers: 109757
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr. Josee Paradis, London Health Sciences Centre:
tonsillectomy
acetaminophen
dexamethasone

Additional relevant MeSH terms:
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anesthetics
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Acetaminophen
BB 1101
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics