This nomogram helps the clinician determine the likelihood of toxicity from this drug in order to make appropriate treatment decisions. Most recently, ibuprofen has achieved over-the-counter status, but unlike APAP, because of insufficient clinical experience, it is not labelled for use in children under the age of two. Fortunately, the efficacy and tolerability of both APAP and ibuprofen have been studied in many well-designed clinical trials in recent years, so that choices can be informed by good evidence. In addition or alternatively, pharmacotherapy can be initiated with either APAP or ibuprofen.
About half of these were conducted after 1990, and the majority included both APAP and ibuprofen treatment groups. In the pursuit of equieffective doses of ibuprofen and APAP in these studies, one or more among six doses of each drug have been compared in a total of 17 different combinations. DRUG EFFICACY In this summary of the efficacy data for the two drugs, APAP is considered standard therapy and various doses of ibuprofen are compared to increasing doses of APAP. ALTERNATING THERAPY At one time it was not uncommon to treat resistant fevers with alternating doses of ASA and APAP, although there were and are no clinical studies supporting this practice, either using these two drugs or with the combination of APAP and ibuprofen.
However, in three other studies that included neither an ibuprofen nor a placebo group, a difference between the two positive treatments being tested was detectable. SUMMARY Results of clinical studies of APAP and ibuprofen for mild to moderate pain in children are not easily translated into straightforward conclusions. In two studies tonsillectomy pain was not improved by APAP or ibuprofen. SAFETY OF ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN AND IBUPROFEN SAFETY DATA FROM CLINICAL TRIALS The safety of APAP and ibuprofen in therapeutic dosages has recently been reviewed in depth by Rainsford et al.
They concluded that both drugs are remarkably safe as used in clinical trials, that there are no statistically significant differences between APAP and ibuprofen in reports of adverse events in any organ system, irrespective of the type or frequency of event. IBUPROFEN SAFETY Like APAP, ibuprofen is remarkably free of side effects when taken in therapeutic doses. In adults, the most common severe adverse effect of intentional overdosing is renal dysfunction, but even after very high ibuprofen doses this is rarely fatal. There are limited data on the risk of renal toxicity in children associated with long term use of ibuprofen, although a prospective study in adults showed no renal impairment.