NCT03902314 - 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)

Guntinas-Lichius O, Volk GF, Geissler K, Komann M, Meissner W
Pain after pediatric otorhinolaryngologic surgery: a prospective multi-center trial. Eur Arch Otorhinolaryngol. 2014 Jul;271(7):2049-60. doi: 10.1007/s00405-014-2914-9. Epub 2014 Feb 9.
Howard D, Davis KF, Phillips E, Ryan E, Scalford D, Flynn-Roth R, Ely E
Pain management for pediatric tonsillectomy: an integrative review through the perioperative and home experience. J Spec Pediatr Nurs. 2014 Jan;19(1):5-16. doi: 10.1111/jspn.12048. Epub 2013 Aug 21. Review.
Koppert W, Ostermeier N, Sittl R, Weidner C, Schmelz M
Low-dose lidocaine reduces secondary hyperalgesia by a central mode of action. Pain. 2000 Mar;85(1-2):217-24.
Vigneault L, Turgeon AF, Côté D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA
Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0. Review.

Lidocaine Infusions for Children Undergoing Combined Tonsillectomy and Adenoidectomy: A Double-Blinded, Randomized, Placebo-Controlled Trial

Clinical trial NCT03902314 - References