NCT02727491 - 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)

Brown KA, Laferrière A, Lakheeram I, Moss IR
Recurrent hypoxemia in children is associated with increased analgesic sensitivity to opiates. Anesthesiology. 2006 Oct;105(4):665-9.
Dawson GS, Seidman P, Ramadan HH
Improved postoperative pain control in pediatric adenotonsillectomy with dextromethorphan. Laryngoscope. 2001 Jul;111(7):1223-6.
Hasan RA, Kartush JM, Thomas JD, Sigler DL
Oral dextromethorphan reduces perioperative analgesic administration in children undergoing tympanomastoid surgery. Otolaryngol Head Neck Surg. 2004 Nov;131(5):711-6.
Kawamata T, Omote K, Kawamata M, Namiki A
Premedication with oral dextromethorphan reduces postoperative pain after tonsillectomy. Anesth Analg. 1998 Mar;86(3):594-7.
Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G
Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
Rose JB, Cuy R, Cohen DE, Schreiner MS
Preoperative oral dextromethorphan does not reduce pain or analgesic consumption in children after adenotonsillectomy. Anesth Analg. 1999 Apr;88(4):749-53.
Silverman DG, O'Connor TZ, Brull SJ
Integrated assessment of pain scores and rescue morphine use during studies of analgesic efficacy. Anesth Analg. 1993 Jul;77(1):168-70.
Steinberg GK, Bell TE, Yenari MA
Dose escalation safety and tolerance study of the N-methyl-D-aspartate antagonist dextromethorphan in neurosurgery patients. J Neurosurg. 1996 May;84(5):860-6.
Weinbroum AA, Rudick V, Paret G, Ben-Abraham R
The role of dextromethorphan in pain control. Can J Anaesth. 2000 Jun;47(6):585-96. Review.

A Prospective Randomized Double-blind Placebo Controlled Trial; Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children?

Details for clinical trial NCT02727491

Clinical trial NCT02727491 - References