Oral Ibuprofen Plus Acetaminophen Versus Ibuprofen Alone for Acute Pain Reduction in Children

In the pediatric emergency department (PED), acute traumatic and nontraumatic pain accounts for approximately 9% of ED visits. The initial drugs of choice for analgesia are typically ibuprofen or acetaminophen. Both drugs display analgesic and antipyretic effects via distinct mechanisms of action. Various meta-analyses in the literature have compared ibuprofen and acetaminophen for pain relief in adults and children. Ibuprofen has been shown to be very effective for mild to moderate pain, especially in musculoskeletal injuries, including some limb fractures.

Combination of analgesics with different modes of action have the potential to offer enhanced pain relief with reduced dosage. Ibuprofen and acetaminophen have different modes of action. Ibuprofen is an NSAID that inhibits the activity of cyclooxygenase-1 and cyclooxygenase-2 enzymes and blocks the synthesis of prostaglandins and thromboxanes. The mode of action of acetaminophen for its analgesic effects is not entirely understood. It is thought that its effects are mediated through serotonergic pathways, cannabinoid and nitric oxide synthase, substance P, and N-methyl-D-aspartate. Combination of ibuprofen and acetaminophen has shown enhanced analgesia in adult studies, with pediatric data limited to post-operative pain and dental pain.

The data is limited regarding the combination of acetaminophen and ibuprofen for acute pain in the PED. A recent study showed similar analgesic efficacy of oral ibuprofen and acetaminophen in comparison with each analgesic alone for short-term treatment of acute pain in the PED7. In this study, pain reassessment was limited to only one time point at 60 minutes and included patients with pain scores of 1 on a 10 point scale. Since there is ample data demonstrating the effectiveness of ibuprofen for pain, we will investigate whether the combination of ibuprofen plus acetaminophen is superior for moderate to severe pain reduction compared to ibuprofen alone.

Objective To evaluate the analgesic efficacy of oral acetaminophen plus ibuprofen versus ibuprofen plus placeboalone for the management of acute pain in a pediatric emergency department.

Hypothesis: The combination of oral acetaminophen and ibuprofen is superior to ibuprofen alone for the reduction of acute traumatic and nontraumatic pain.