The study will be performed prospectively and in a randomized, double-blinded, placebo
controlled manner. Patients meeting inclusion and not violating exclusion criteria will
be randomized to either receive a single oral steroid dose or a single placebo dose on
the third day after surgery. All study patients will otherwise receive the standard of
care in all other aspects of their treatment. That is, the surgery itself, the
post-operative pain control strategies/medication, patient instructions, and follow up
will not differ between the two groups. The pediatric otolaryngology department has
standardized post-operative pain control (a specific order set is used) which will ensure
no differences between different providers.
Oral dexamethasone is the study drug and will be given in 0.5mg/kg dosage and the route
is 3mg capsules in increments of one capsule. Doses are calculated by weight and rounded
up to the nearest 3mg up to a maximum of 12mg (4 capsules). Parents are instructed to
give the medication on the morning of the third day after surgery. Parents can either
have the child swallow the capsule or, if the child does not tolerate this, open the
capsule and mix the contents into food the consistency of applesauce, then administer. A
placebo will also be designed in the same route as the oral dexamethasone. Both the
placebo and oral dexamethasone capsules will be purchased from by Tidewater Pharmacy and
Compounding, an accredited pharmacy located in Mt. Pleasant, South Carolina12. Weight
based instructions will be included with the study materials. During distribution, the
member of the study team delivering the study materials will confirm the dosing with the
parents.
Study materials will be assembled and randomized by the project lead, and will include a
small container with four capsules of either placebo or oral dexamethasone. All study
materials will be assigned a unique record number between 001 and 150. The materials will
be block-randomized in groups of 30 to either contain placebo or oral dexamethasone, and
linked to the record number in a secured file held by the project lead. This file will be
inaccessible to any but the project lead during data collection. The study materials with
the drug or placebo will be kept in a temperature controlled locked cabinet at the study
site, MUSC Children's Health R. Keith Summey Medical Pavilion.
Immediately following the procedure in the operating room, once lack of exclusion
criteria has been confirmed by the operating surgeon, patients will be assigned a subject
record number in numerical order. This record number will be recorded, linked to the
patient's medical record number, and kept in a secure file separate from the
randomization list. The randomization process will be blinded from the parents, subjects,
study coordinator, and operating surgeon. The subject's parents will then receive study
materials that correspond to their unique record number, which will include either four
3mg dexamethasone capsules or four placebo capsules. Weight based instructions will be
included with this dosing, and providers and/or research team members will go over these
instructions with parents again when giving the study materials.
After randomization, the operating surgeon will complete a questionnaire to document
details of the surgery, including: who performed the surgery, intracapsular versus
extracapsular tonsillectomy, estimated blood loss, and use of suction cautery on the
tonsillar bed. This will be collected by the study coordinator and linked to the patient
record number.
Patients enrolled in the study will receive a "post-operative pain and medication diary"
upon discharge from their procedure. Patients (parents) will be instructed to record
daily pain control (on a validated visual analog scale (VAS)) and daily medication
administration (opioid and non-opioid analgesic) for post-operative days 0-6 in this
diary. Patients will return the diary to the study team via email, fax, text message, or
a pre-addressed, stamped envelope. Reminders to return the materials will be sent to the
parents periodically by the study coordinator via email, text message, or phone call.
Recall bias will be reduced by the incorporation of the diary to aid parents' memory. The
study coordinator will transcribe pain control and medication consumption data into the
REDCap data compilation system.
The Faces Pain Scale-Revised13 will be used to assess patient pain on post-operative day
0-6. The scale will be provided to the patient in their discharge packet and a diary to
record daily pain score will be provided. Mean VAS for post-operative day 1-3 and mean
VAS for post-operative day 4-6 will be calculated for comparison.
Daily medication administration will be recorded by parents, specifically the number of
doses of opioid and non-opioid analgesic medication consumed. For opioids, doses consumed
will be cross-referenced against the weight-based dose prescribed in order to calculate
daily oral morphine equivalents (OME) consumed. Mean daily OME will be calculated for
post-operative day 1-3 and for post-operative day 4-6 for comparison.
At 30-days following surgery, participant patient charts will be queried by the study
coordinator for presentation to the emergency room, readmission, and oropharyngeal
hemorrhage. Presentation to the emergency room and readmission will be included if
considered related to the procedure. Related emergency room presentation or readmission
is defined as that due to throat pain, neck pain, ear pain, poor oral intake due to pain,
dehydration due to poor oral intake caused by pain, and bleeding from the mouth or nose.
Regarding oropharyngeal hemorrhage, any subjective or objective bleeding from the mouth
or nose within 30 days of the procedure will be considered related to the procedure.
Oropharyngeal hemorrhage will be divided into three groups: mild (not requiring
admission, manifested as phone call or presentation to the emergency room), moderate
(requiring admission but not return to the operating room), and severe (requiring urgent
or emergent intubation and/or control of hemorrhage in the operating room).
If patients are experiencing pain uncontrolled by oral medications after tonsillectomy,
providers at our institution will occasionally choose to give a dose of steroids prior to
the third postoperative day or a second dose of steroids after the third postoperative
day to help with pain control. If study patients have pain prior to the third
postoperative day and a provider believes steroids are indicated, the patient should be
given this medication, and then will be instructed not to take the study medication and
will be excluded from analysis. If patients have pain on the third postoperative day and
have already taken the study medication, they will be instructed to wait at least 6 hours
before receiving another dose of steroids. All of this will be discussed in detail when
obtaining consent, and will be included in the study materials given to parents.
