drugset / Trial / NCT02265822
Melatonin Premedication in Children Undergoing Surgery
Phase 4
Completed
92 enrolled
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Eloisa Gitto · collabGabriella D'Angelo · collabLucia Marseglia · collabPietro Impellizzeri · collabSara Manti · collabSimona Montalto · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Melatonin has been proposed as alternative to midazolam as a premedication in procedures preceding anaesthesia induction. The objective of this prospective, randomized, double-blind study is to investigate the possible effect of melatonin premedication on the required infusion of propofol in comparison to midazolam, evaluating the efficacy of oral melatonin on sedation in children undergoing surgery. Preoperative anxiety and postoperative analgesia are also assessed in both groups.
Timeline
- Start
- 2012-09
- Primary completion
- 2013-10
- Completion
- 2013-10
Publications
- Results Acil M, Basgul E, Celiker V, Karagoz AH, Demir B, Aypar U. Perioperative effects of melatonin and midazolam premedication on sedation, orientation, anxiety scores and psychomotor performance. Eur J Anaesthesiol. 2004 Jul;21(7):553-7. doi: 10.1017/s0265021504007094.
- Results Naguib M, Gottumukkala V, Goldstein PA. Melatonin and anesthesia: a clinical perspective. J Pineal Res. 2007 Jan;42(1):12-21. doi: 10.1111/j.1600-079X.2006.00384.x.
- Results Naguib M, Samarkandi AH, Moniem MA, Mansour Eel-D, Alshaer AA, Al-Ayyaf HA, Fadin A, Alharby SW. The effects of melatonin premedication on propofol and thiopental induction dose-response curves: a prospective, randomized, double-blind study. Anesth Analg. 2006 Dec;103(6):1448-52. doi: 10.1213/01.ane.0000244534.24216.3a.
- Results Kurdi MS, Patel T. The role of melatonin in anaesthesia and critical care. Indian J Anaesth. 2013 Mar;57(2):137-44. doi: 10.4103/0019-5049.111837.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 0.2 mg/kg | Oral |
| Comparator | Midazolam | Small molecule | 0.5 mg/kg | Oral |
Indications
No indication recorded.