medwireNews: Patients who are treated with ibuprofen alone experience comparable pain control in the first day after hip replacement to those give acetaminophen plus ibuprofen, findings from the PANSAID trial suggest.
As reported in JAMA, median 24-hour morphine consumption following total hip replacement was 26 mg for the 139 patients who were randomly assigned to receive the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen at a dose of 400 mg every 6 hours plus placebo, compared with 20 mg for the 136 patients given acetaminophen 1000 mg plus ibuprofen 400 mg every 6 hours, giving a nonsignificant between-group difference of 6 mg.
Compared with ibuprofen alone, the morphine-sparing effect of acetaminophen plus ibuprofen was “below the [10 mg] prespecified threshold for clinically important postoperative morphine reduction,” say the PANSAID (Paracetamol and NSAID in combination) trial investigators.
By contrast, patients treated with the combination had significantly lower median 24-hour morphine consumption than the 142 participants given acetaminophen (1000 mg every 6 hours) plus placebo, at 20 mg versus 36 mg.
This finding supports “the principle of multimodal analgesia with [acetaminophen] plus ibuprofen compared with [acetaminophen] alone for the first postoperative day,” write Kasper Højgaard Thybo (Næstved Hospital, Denmark) and colleagues.
However, they say that because ibuprofen resulted in a similar reduction in postoperative morphine consumption compared with the combination of both drugs without increasing the risk for serious adverse events (SAEs), “ibuprofen alone may be a reasonable option for early postoperative oral analgesia.”
In all, 20 patients in the ibuprofen only group, 26 patients given the combination, and 15 patients taking paracetamol only experienced one or more SAEs within 90 days of surgery. A comparable proportion of patients in the three groups experienced adverse events of any grade in the first 24 hours of surgery, at rates of 16%, 15%, and 16%, respectively.
Thybo and team note that their trial had a number of limitations, including an intervention period of only 24 hours, and limited statistical power to detect differences in SAE rates between the groups.
“[A] prolonged intervention period could have been more appropriate as treatment with [acetaminophen] plus ibuprofen seldom is used for only 24 hours in a clinical context,” they write.
The researchers conclude: “Equal focus on benefits and harms is recommended to be common practice of clinical trials, and further trials focusing on safety of NSAIDs in the perioperative period are urgently needed.”
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