NCT02964416 - 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)

Ferber J, Juniewicz H, Glogowska E, Wronski J, Abraszko R, Mierzwa J
Tramadol for postoperative analgesia in intracranial surgery. Its effect on ICP and CPP. Neurol Neurochir Pol. 2000;34(6 Suppl):70-9.
Lin BF, Ju DT, Cherng CH, Hung NK, Yeh CC, Chan SM, Wu CT
Comparison between intraoperative fentanyl and tramadol to improve quality of emergence. J Neurosurg Anesthesiol. 2012 Apr;24(2):127-32. doi: 10.1097/ANA.0b013e31823c4a24.
Lintz W, Beier H, Gerloff J
Bioavailability of tramadol after i.m. injection in comparison to i.v. infusion. Int J Clin Pharmacol Ther. 1999 Apr;37(4):175-83.
Mikawa K, Nishina K, Maekawa N, Obara H
Attenuation of cardiovascular responses to tracheal extubation: verapamil versus diltiazem. Anesth Analg. 1996 Jun;82(6):1205-10.
Neelakanta G, Miller J
Minimum alveolar concentration of isoflurane for tracheal extubation in deeply anesthetized children. Anesthesiology. 1994 Apr;80(4):811-3.
Rahimi SY, Alleyne CH, Vernier E, Witcher MR, Vender JR
Postoperative pain management with tramadol after craniotomy: evaluation and cost analysis. J Neurosurg. 2010 Feb;112(2):268-72. doi: 10.3171/2008.9.17689.
Sudheer PS, Logan SW, Terblanche C, Ateleanu B, Hall JE
Comparison of the analgesic efficacy and respiratory effects of morphine, tramadol and codeine after craniotomy. Anaesthesia. 2007 Jun;62(6):555-60.
Valley RD, Ramza JT, Calhoun P, Freid EB, Bailey AG, Kopp VJ, Georges LS
Tracheal extubation of deeply anesthetized pediatric patients: a comparison of isoflurane and sevoflurane. Anesth Analg. 1999 Apr;88(4):742-5.

Effect of Single Dose of Tramadol on Extubation Response and Quality of Emergence(Cough and Nausea Vomiting) Following Supratentorial Intracranial Surgery

Details for clinical trial NCT02964416

Clinical trial NCT02964416 - References