A Randomized, Double-blinded, Placebo-controlled Study of Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy

Tonsillectomy/adenoidectomy is an elective operation, mainly in the pediatric population. This procedure is performed by Dr. Jason Mouzakes and the otolaryngology residents under his supervision. The location of the research is at the Albany Medical Center Hospital, Main Campus and South Clinical Campus. Duration of this study for each individual patient will be set at 14 days post procedure, taking into account that bleeding risk with this procedure is highest within the first 2 weeks post-operatively. Data will be obtained within 90 days after discharge from the hospital by telephone interview with the parents or hospital record. The investigators plan to enroll at least 600 patients, 300 in each group, ASA physical status I to III and age 2 years to 18 years old (inclusive). Parents and children may be informed about the study at the time when surgery is planned during initial office visit. Enrollment in the study will be done on the day of the surgery, after the Anesthesiologist or Otolaryngology/Anesthesiology Resident explains the purpose, benefits and possible risks of the study and answers all questions of the parents. Before enrollment is finalized, informed consent and informed assent, if applicable, to take part in a human research study will be obtained.

At the completion of surgery, patients will be transferred to the post-anesthesia care unit (PACU). Additional pain medication if needed in the PACU will be acetaminophen 15mg/kg oral solution or opioid medications at discretion of treating anesthesiologist. Acetaminophen will only be given in PACU if it was not received pre-operatively. Patients will be discharged to home from the PACU or 2nd level short-stay recovery unit (at South Clinical Campus) when standard criteria are met for each patient per protocol.

Randomization Plan:

Patients will be randomized by a card system. There will be 600 cards with 300 labeled (K) for ketorolac group and 300 labeled (NS) for placebo group along with the assigned subject number. Preservative free 0.9% normal saline will be used as placebo. Randomization will be done using www.randomization.com which will generate a randomization sequence with a concealed blocking schedule. A non-investigator will prepare envelopes numbered sequentially, each containing a card indicating the subject number (sequentially numbered 1 - 600) and group as randomized by above plan. Envelopes are opened only upon obtaining consent maintaining allocation concealment until treatment is initiated. Patients are therefore assigned a subject number at the initiation of the study. The non-treating anesthesiologist will open the next sequential envelope (starting from envelope #1) and draw up the specified drug and give the drug with a patient label to the treating anesthesiologist. The non-treating anesthesiologist will also tell the treating anesthesiologist the patient's subject number so it may be recorded on the individual data collection sheet. The non-treating anesthesiologist will place a patient label on the drug card and store the card in the anesthesiology office, specifically Dr Afroze's office inside of room D108. Dr Afroze's office is locked and has minimal access. The patient drug cards will be accessed by the research team two weeks after the surgery date to record patient data.

The PACU nurses, surgeon, residents, and treating anesthesiologist will all be blinded and may perform the PACU scoring and data collection. Study drugs will be documented the same exact way on the anesthesia records for all the study patients. All the study patients' charts will have both drugs documented as IN study drug dose in mg. The doses of the drugs are pre-calculated based on the patient's weight and will be drawn by a non-treating anesthesiologist and administered by the treating anesthesiologist at the time of the surgery.