Jun 27 2011
An essential aspect of oral surgery is controlling the patient's pain following a procedure. The goal is to relieve pain and promote a rapid recovery, without opioid side effects. An initial study shows that Dyloject, a new intravenous form of the drug diclofenac, has promise for achieving these goals.
An article in the current issue of the journal Anesthesia Progress compares two intravenous nonsteroidal anti-inflammatory drugs (NSAIDs)—diclofenac and ketorolac—along with a placebo. Only ketorolac is currently approved for this usage in the United States; intravenous diclofenac was recently approved in the United Kingdom.
In this study, 353 patients were given one of these drugs or a placebo following oral surgery. This was a single-dose, randomized, double-blind, parallel group study conducted at three sites. The patients had undergone surgical extraction of one or more third molars, which typically leads to moderate to severe pain. The procedure creates a challenge for pain control and an opportunity to evaluate analgesics.
Total pain relief over 6 hours, as measured by the visual analog scale, was considered the endpoint for this study. Other indicators of efficacy researched included measures of pain intensity and relief, and time to pain relief. Adverse effects were also monitored and found to be minimal.
Intravenous diclofenac was given in five different dosages, ranging from 3.75 mg to 75 mg, while ketorolac was given in a 30-mg dose. The study sought to define the minimum dose of intravenous diclofenac that gave an analgesic effect noticeably different from the placebo. In meeting the endpoint of 6-hour pain relief, diclofenac rated better than the placebo in all but the lowest dosage.
This research found that intravenous diclofenac worked more quickly than ketorolac. A significantly higher proportion of patients given intravenous diclofenac reported 30% or greater pain relief after 5 minutes compared with those given ketorolac or the placebo.
The findings indicate additional clinical benefit from the use of intravenous diclofenac. Larger scale trials in more diverse populations are needed and, should they confirm the findings of this study, have the potential to improve the safety and efficacy of postoperative NSAID analgesia.