Commonly used ibuprofen may not be the safest pain relief option for all children following tonsillectomy due to an elevated risk for significant post-operative bleeding when compared to acetaminophen, according to a new randomized trial from Massachusetts Eye And Ear/Harvard Medical School. Published online on April 4 in JAMA Otolaryngology, these findings should lead doctors to counsel parents on this risk following tonsil removal. They may also want to consider alternative options for pain relief such as acetaminophen as a treatment, according to the study’s authors.
"We were really hoping to show that children’s ibuprofen was just as safe, but we really cannot conclude that based on these new findings,” says Gillian R. Diercks, MD, MPH, an Instructor in Otolaryngology–Head and Neck Surgery at Harvard Medical School and pediatric otolaryngologist at Mass. Eye and Ear. “This should give physicians pause when counseling their patients, who should rethink whether ibuprofen should be given to every patient or used as liberally following tonsillectomy.”
In a multicenter trial, Dr. Diercks and colleagues randomized 741 children ages two to 18 to take either 10mg/kg ibuprofen or 15 mg/kg acetaminophen every six hours for the first nine days following a tonsillectomy when postoperative bleeding risk is highest; 688 were eligible for the study. Twenty-seven children in the acetaminophen group (7.9 percent) and 38 children in the ibuprofen group (11 percent) experienced at least one postoperative bleeding event. A statistical analysis looking at severe bleeding that required a trip back to the operating room found that 1.2 percent in the acetaminophen group and 2.9 percent in the ibuprofen group experienced a severe bleed. In the acetaminophen group, 7.4 percent of bleeds were recurrent, while 15.8 percent of bleeds were recurrent in the ibuprofen group.
Dr. Diercks says more resources should be devoted toward identifying and developing safe and effective pain medicines for children after tonsil surgery. She adds that future studies should look at whether ibuprofen in smaller doses, or when combined with acetaminophen, may reduce this risk. She notes that previous studies have looked at population rates or in retrospective chart review — and this randomized trial suggests there may be a problem that physicians are missing, warranting additional research.
Tonsillectomies are one of the most common surgical procedures in children, with up to 530,000 cases performed in the U.S. each year. Pain can last up to two weeks for some children after surgery, and controlling with medications is important to allow for eating, drinking, and avoiding dehydration.
The Food and Drug Administration released a black box warning in 2017 against children receiving codeine after a tonsillectomy due to risk of life-threatening breathing problems in children. Children with obstructive sleep apnea may be at significant risk taking other opioid narcotics as well. Ibuprofen has previously been linked to increased bleeding risks; however, it had not been well studied in children underdoing tonsillectomy despite being included as a potential pain management option in guideline recommendations.