NCT05757388 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Brett CN, Barnett SG, Pearson J
Postoperative plasma paracetamol levels following oral or intravenous paracetamol administration: a double-blind randomised controlled trial. Anaesth Intensive Care. 2012 Jan;40(1):166-71. doi: 10.1177/0310057X1204000121.
Kehlet H, Jensen TS, Woolf CJ
Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
Nonaka T, Hara M, Miyamoto C, Sugita M, Yamamoto T
Comparison of the analgesic effect of intravenous acetaminophen with that of flurbiprofen axetil on post-breast surgery pain: a randomized controlled trial. J Anesth. 2016 Jun;30(3):405-9. doi: 10.1007/s00540-016-2150-0. Epub 2016 Feb 16.
Schug SA, Parsons B, Li C, Xia F
The safety profile of parecoxib for the treatment of postoperative pain: a pooled analysis of 28 randomized, double-blind, placebo-controlled clinical trials and a review of over 10 years of postauthorization data. J Pain Res. 2017 Oct 10;10:2451-2459. doi: 10.2147/JPR.S136052. eCollection 2017.
Schug SA
The role of COX-2 inhibitors in the treatment of postoperative pain. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S82-6. doi: 10.1097/00005344-200605001-00015.
Woolf CJ, Max MB
Mechanism-based pain diagnosis: issues for analgesic drug development. Anesthesiology. 2001 Jul;95(1):241-9. doi: 10.1097/00000542-200107000-00034. No abstract available.

The Efficacy of Intraoperative Parecoxib Combined With Paracetamol for Reducing Opioid Consumption in Patients Undergoing Breast Cancer Surgery Under General Anesthesia: A Prospective Randomized Controlled Trial

Details for clinical trial NCT05757388

Clinical trial NCT05757388 - References