NCT02669004 - 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)

Borgeat A, Blumenthal S
Postoperative pain management following scoliosis surgery. Curr Opin Anaesthesiol. 2008 Jun;21(3):313-6. doi: 10.1097/ACO.0b013e3282f82baa. Review.
Gauger VT, Voepel-Lewis TD, Burke CN, Kostrzewa AJ, Caird MS, Wagner DS, Farley FA
Epidural analgesia compared with intravenous analgesia after pediatric posterior spinal fusion. J Pediatr Orthop. 2009 Sep;29(6):588-93. doi: 10.1097/BPO.0b013e3181b2ba08.
Taenzer AH, Clark C
Efficacy of postoperative epidural analgesia in adolescent scoliosis surgery: a meta-analysis. Paediatr Anaesth. 2010 Feb;20(2):135-43. Review.

Patient-controlled Intermittent Epidural Bolus Versus Epidural Infusion for Posterior Spinal Fusion After Adolescent Idiopathic Scoliosis

Clinical trial NCT02669004 - References