- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03323047
Perioperative Tonsillectomy Protocol Development
Perioperative Tonsillectomy Protocol Development for Preoperative Acetaminophen and Intraoperative High Dose Dexamethasone: a Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted as a prospective, randomized, longitudinal, double-blinded trial at a single ambulatory surgery centre with 3 groups of 20 children. Group 1 will receive oral acetaminophen (15 mg/kg) 1 hour pre-operatively and high-dose intravenous dexamethasone (0.5 mg/kg, max. dose 10 mg) immediately after induction of anesthesia. Group 2 will receive oral acetaminophen elixir (15 mg/kg) 1 hour pre-operatively and low-dose intravenous dexamethasone (0.15 mg/kg, maximum of 8 mg) immediately after induction of anesthesia. Group 3 will receive an oral placebo 1 hour pre-operatively and low dose intravenous dexamethasone (0.15 mg/kg, maximum of 8 mg) immediately after induction of anesthesia. Dose of dexamethasone is a potential confounder if patients in the low-dose dexamethasone groups weigh enough to obtain the maximum dose (8 mg). We expect this occurrence to be rare, as dexamethasone will be dosed for ideal bodyweight, but subgroup analysis by actual dose received will be performed to compare the two dosing regimens (0.15mg/kg and 0.5 mg/kg).
In addition to these medications, patients will receive the standard peri-operative care at our centre, which consists of intra- operative ondansetron at the discretion of the anesthesiologist, and standing orders for acetaminophen (15 mg/kg) and ibuprofen (10 mg/kg) around the clock. Patients older than five years also receive morphine elixir (0.1 mg/kg rounded down to the nearest 0.5 mg) p.r.n (when necessary) at the discretion of the nurse. Thus, patients of all three groups will receive adequate post-operative symptom control. The Pediatric Otolaryngologist (Dr. Josee Paradis, Dr. Julie Strychowsky, or Dr. Murad Husein) who is the patient's physician and will be performing the tonsillectomy, will initially approach the participant and substitute decision maker (SDM) to describe the study. If the patient and SDM agree to consider the study, the study will be described in more detail and study consent/assent will be obtained by a research assistant or a physician (who is not the primary physician). We will recruit a convenience sample of 60 patients aged 3-13 years scheduled for tonsillectomy to be performed by the principal investigator or co-investigators (J.P., M.H. or J.S.). For children aged 3 to 6 years, SDM informed consent will be obtained; for children aged 7 to 12 years, SDM written consent and child assent will be requested; for children 13 years of age, written consent will be obtained from a SDM and from the child. The patients will be randomized to one of the three treatment groups by a computerized randomization table. Data from the tonsillectomy procedure, including whether analgesia was needed intraoperatively, and in the post-anesthesia care unit, will be recorded. Self-reported pain intensity will be scored on the Oucher tool, a number and picture scale validated in children age 3-13. A research assistant or nurse will be trained to obtain Oucher reports at the patient's bedside at specific post-operative events, which correspond to time points. The Oucher tool is simple to learn and takes minimal time to administer. The first pain report will be obtained once the patient wakes from anesthesia (15 - 45 min post- operation), then upon transfer to step-down care (1 - 2 hrs hour post-operation), then at 3 hours post-operation, and finally upon discharge (or at 5 hours post-operation, if the patient is not anticipated to be discharged by this time). Many of the details surrounding the operation will be gathered in post-hoc review of the patient's chart by the research assistant. If the patient is transferred from the PACU to the day surgery unit (i.e. discharge is anticipated before the end of the day), the information from the entire stay in the day surgery will be collected. If the patient is admitted to the floor (i.e. staying overnight in the hospital for observation), information will be collected from the first 4 hours after admission. The information gathered from the chart will include complications of surgery, whether or not the patient had post-operative bleeding requiring a change in management, and also whether or not the patient had post-operative bleeding that required an operating room procedure. Time to first oral fluid intake, as well as amount of oral intake (measured in quantity of popsicles) in the post-anesthesia care unit and total oral intake before discharge will also be gathered from the patient's chart, as well as the time to first administration of morphine, the dose of morphine required, and the frequency of post-operative vomiting until time of discharge. For home pain management, all patients are advised to take acetominophen (15mg/kg) every 6 hours as needed, alternating with ibuprofen (10mg/kg) every 6 hours as needed. At discharge (average 5 hours post-operation), parents/guardians will be provided with a package including the Pediatric Quality of Life Inventory with questions about oral intake and activity, as well as a space to record any incidents of vomiting, the Oucher tool to evaluate the patient's pain severity, and a medication log to keep track of the pain medication (over the counter or prescribed) that the patient has taken. Parents/guardians will be given a measured cup to record quantity of oral fluid intake for the day. Parents will be asked to fill out the first questionnaire at discharge (average 5 hours post-operation) time point, and they will be encouraged to raise any questions or concerns they have about how to complete the questionnaires. Subsequently, these instruments will be completed by parents/guardians (relationship to patient will be noted on each form and they will be encouraged to have the same parent/guardian complete the form each time) on post-operative days 1, 2, 3, 4, 5, 6, and 7 before bedtime. The research assistant will contact parents/guardians and patients by telephone on the first postoperative day to follow-up with any questions or concerns about the survey. On the last weekday before the patient's follow-up appointment, a reminder call will be made to ask the parent/guardian to bring their completed questionnaire to the appointment. On the 14th post-operative day patients will attend a follow-up visit where they will be assessed and their completed forms will be collected. If the patient had any emergency department visits related to the procedure, the research assistant will consult the hospital database to obtain information about the emergency department visit, including date, chief complaint, and management.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Josee Paradis, MD
- Phone Number: 519.685.8794
- Email: Josee.Paradis@lhsc.on.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada
- Recruiting
- Children's Hospital
-
Contact:
- Alexandria Houston
- Phone Number: 57125 519-685-8500
- Email: Alexandria.Houston@lhsc.on.ca
-
Principal Investigator:
- Josee Paradis, MD
-
Sub-Investigator:
- Julie Strychowsky, MD
-
Sub-Investigator:
- Murad Husein, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
Oral acetaminophen (15 mg/kg) 1 hr pre-operatively
Other Names:
Intravenous high-dose dexamethasone (0.5 mg/kg, max. 10 mg) immediately after induction of anesthesia
Other Names:
|
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
|
Oral acetaminophen (15 mg/kg) 1 hr pre-operatively
Other Names:
Intravenous low-dose dexamethasone (0.15 mg/kg, max.
8 mg) immediately after induction of anesthesia
Other Names:
|
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.
|
Intravenous low-dose dexamethasone (0.15 mg/kg, max.
8 mg) immediately after induction of anesthesia
Other Names:
Oral placebo 1 hr pre-operatively
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
awakening from anesthesia (0.5 hours post- operation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesia use
Time Frame: during operation
|
Whether or not intraoperative analgesia was required
|
during operation
|
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
|
during patient's stay in PACU (on average 5 hours)
|
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)
|
during patient's stay in PACU (on average 5 hours)
|
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
|
from end of operation to 7 days post-operation
|
vomiting
Time Frame: From end of operation to 7 days post-operation
|
Number of times patient vomited after surgery
|
From end of operation to 7 days post-operation
|
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
|
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
|
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
|
discharge (on average 5 hours post-operation) to 7 days post-operation
|
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).
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Josee Paradis, MD, LHSC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Pharyngitis
- Tonsillitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antipyretics
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Acetaminophen
- Dexamethasone 21-phosphate
Other Study ID Numbers
- 109757
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tonsillitis
-
Turku University HospitalRecruitingTonsillitis | Tonsillitis Chronic | Tonsil Disease | Tonsillitis AcuteFinland
-
Aarhus University HospitalSkodstrup Medical Clinic, DenmarkUnknownStreptococcal Acute TonsillitisDenmark
-
Oulu University HospitalCompletedTonsillitis Chronic | Tonsillitis RecurrentFinland
-
Assiut UniversityUnknownAcute Follicular Tonsillitis
-
China Academy of Chinese Medical SciencesBeijing Chao Yang Hospital; The First Affiliated Hospital of Henan University... and other collaboratorsUnknownAcute Tonsillitis
-
Combined Military Hospital, PakistanCompleted
-
Bait Balev HospitalUnknownTonsillitis | Tonsillitis StreptococcalIsrael
-
Pamukkale UniversityCompletedOSAS | Recurrent TonsillitisTurkey
-
Pamukkale UniversityRecruitingSleep Apnea | Tonsillitis RecurrentTurkey
-
HaEmek Medical Center, IsraelCompletedViral Pharyngitis | Viral TonsillitisIsrael
Clinical Trials on Acetaminophen
-
Massachusetts General HospitalCompletedPain, Postoperative | Infertility, FemaleUnited States
-
Kaveh Aslani, MDCompletedAirway Obstruction | Tonsillitis | Difficulty SwallowingUnited States
-
Taipei Medical University WanFang HospitalUnknownCervical Radiculopathy | Radicular Pain | Acute Neck Pain | Cervicobrachial PainTaiwan
-
Medical University of South CarolinaCompletedPain, PostoperativeUnited States
-
MallinckrodtTerminatedAcute Pain, PostoperativeUnited States
-
Duke UniversityCompletedOsteoarthritis | Acetaminophen | Arthroplasty, Hip ReplacementUnited States
-
Spectrum Health HospitalsTerminatedHip FractureUnited States
-
Babiash, Kimberly H., M.D.Unknown
-
Jiangsu HengRui Medicine Co., Ltd.Active, not recruiting
-
Beth Israel Deaconess Medical CenterNational Center for Research Resources (NCRR); Harvard UniversityCompletedAcetaminophen Poisoning | Acetaminophen Metabolism | Drug Metabolism by ExcipientsUnited States