The study shows over-the-counter ibuprofen manages pain after a tonsillectomy for children and adults as well as the prescription pain medications acetaminophen with hydrocodone and acetaminophen with codeine, which is no longer recommended for use in children.
"Based on this study and the FDA warning about the risks of children taking any medication with codeine, we recommend that children receive over-the-counter ibuprofen after a tonsillectomy," says lead study author Robert T. Standring, M.D., with the Department of Otolaryngology-Head & Neck Surgery at Henry Ford.
"Ibuprofen appears to be the safest alternative that still provides adequate pain control for children."
Study results will be presented Tuesday, Oct. 1 at the 2013 American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) annual meeting in Vancouver, BC.
Tonsillectomy, the surgical removal of the tonsils, is the second most common out-patient surgery for children younger than age 15. Each year, an estimated 662,000 children undergo a tonsillectomy.
Pain is the primary source of illness following a tonsillectomy, causing dehydration, difficulty and painful swallowing, and weight loss. These symptoms can lead to increased post-operative visits and hospital readmission.
In 2012, the FDA recommended that children not be given medication with codeine due to associated risks. Additionally, in 2011 the AAO-HNS published a clinical Practice Guideline on tonsillectomy in children, recommending a weight-based pain regimen be given based on pain scores of patient.
With these changes, the Henry Ford study sought to investigate a safe and effective oral post-operative pain regimen for both children and adults following tonsillectomy.
For the study, Dr. Standring and study co-author Kathleen Yaremchuk, M.D., enrolled 91 patients in the study of varying age from June 2011 to August 2013, all of whom underwent the same surgical procedure to remove their tonsils. Patients ranged in age from 3 to 38.
During the pre-operative evaluation, patients were given a packet, randomly assigning them to one of three pain regimens -- ibuprofen, acetaminophen with hydrocodone, or acetaminophen with codeine. The pain regimen was appropriately dosed by the patient's weight.
The packet also included a post-operative evaluation form, wherein patients and/or their families were asked to rate their pain twice daily on a scale of 1 to 10, using a validated pediatric pain scale. Pain was recorded for the 10 days after surgery.
Patients were also asked to record the amount of pain medication given, as well as the amount of liquid or food consumed. Finally, patients were asked to list the day that they returned to work or school, and any complications with the procedure or the medication.
Twenty-five patients completed the post-operative package. Twelve took ibuprofen, eight took acetaminophen with hydrocodone, and five took acetaminophen with codeine. When the FDA issued a warning on the use of codeine in children, the researchers stopped enrolling children in that arm of the study.
When comparing all three patient groups, the researchers found no significant difference in pain control. All three pain relievers caused a significant decline in pain scores over time and had no significant difference in the time it took for patients to return to work or school, as well as their regular diet and activities.
The researchers noted, however, that during certain points in time acetaminophen with codeine showed a significant improvement in pain.