The Effect of Pre-emptive Oral Melatonin versus Placebo on Post-operative Analgesia in Infants after Thoracotomy for Closed Cardiac Surgeries: A Randomized Controlled Study
DOI:
https://doi.org/10.3889/oamjms.2022.10282Keywords:
Thoracotomy, Premedication, Melatonin, Post-operative analgesiaAbstract
BACKGROUND: Thoracotomy pain is one of the severest types of pain that should be managed properly, especially in children. Opioids are the most widely prescribed analgesics for post-operative pain, but they can have a number of undesirable side effects. Melatonin could be employed as an adjuvant analgesic therapy during procedural discomfort as it had no known major side effects.
STUDY DESIGN: This was a double-blinded, controlled randomized study.
METHODS: Fifty patients divided randomly into two equal groups. One hour before surgery, children in M group (n = 25) were given 0.5 mg/kg orally of melatonin 3 mg tablets) and patients in Group P (n = 25) received a placebo (5 ml of water by syringe 5 ml) orally. Post-operative pethidine consumption over the 1st 24 h (mg) was recorded, the intraoperative fentanyl consumption (HR and ABP) at baseline, 1 min after induction, at skin incision, and every 30 min till the end of the surgery were recorded. Neonatal Infant Pain Score (NIPS) at 4 h, 6 h, 8 h, 12 h, 18 h, and 24 h postoperatively was recorded. Other reported data include demographic data, extubation time, days of ICU stay, and complications.
RESULTS: Total post-operative pethidine consumption (mg) over 24 h was significantly lower in M group than P group (3.48 ± 2.23 vs. 7.68 ± 4.52 p = 0.01). Intraoperative fentanyl consumption (ug) was significantly lower in M group than P group (10.28 ± 4.98 vs. 17.08 ± 7.39 p < 0.001). As regards NIPS, it was statistically lower in M group than P group in all times except at 8 h and 24 h with significant difference.
CONCLUSION: Oral melatonin is an effective and safe pre-emptive drug as it reduces the total post-operative pethidine consumption over the first 24 h and decreased post-operative pain scores without any unpleasant effects in pediatrics undergoing closed heart surgery.Downloads
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Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011;24(1):8-12. https://doi.org/10.1097/ACO.0b013e3283414175 PMid:21084984 DOI: https://doi.org/10.1097/ACO.0b013e3283414175
Gottschalk A, Cohen SP, Yang S, Ochroch EA. Preventing and treating pain after thoracic surgery. Anesthesiology. 2006;104(3):594-600. https://doi.org/10.1097/00000542-200603000-00027 PMid:16508407 DOI: https://doi.org/10.1097/00000542-200603000-00027
Dahl JB, Møiniche S. Pre-emptive analgesia. Br Med Bull. 2004;71:13-27. https://doi.org/10.1093/bmb/ldh030 PMid:15596866 DOI: https://doi.org/10.1093/bmb/ldh030
Gitto E, Marseglia L, Manti S, D’Angelo G, Barberi I, Salpietro C, et al. Protective role of melatonin in neonatal diseases. Oxid Med Cell Longev. 2013;2013:980374. https://doi.org/10.1155/2013/980374 PMid:24349616 DOI: https://doi.org/10.1155/2013/980374
Patel S, Naeem S, Kesingland A, Froestl W, Capogna M, Urban L, et al. The effects of GABA(B) agonists and gabapentin on mechanical hyperalgesia in models of neuropathic and inflammatory pain in the rat. Pain. 2001;90:217-26. https://doi.org/10.1016/S0304-3959(00)00404-8 PMid:11207393 DOI: https://doi.org/10.1016/S0304-3959(00)00404-8
Gitto E, Aversa S, Salpietro CD, Barberi I, Arrigo T, Trimarchi, G, et al. Pain in neonatal intensive care: Role of melatonin as an analgesic antioxidant. J Pineal Res. 2012;52:291-5. https://doi.org/10.1111/j.1600-079X.2011.00941.x PMid:22141591 DOI: https://doi.org/10.1111/j.1600-079X.2011.00941.x
Yousaf F, Seet E, Venkatraghavan L, Abrishami A, Chung F. Efficacy and safety of melatonin as an anxiolytic and analgesic in the perioperative period: A qualitative systematic review of randomized trials. Anesthesiology. 2010;113(4):968-76. https://doi.org/10.1097/ALN.0b013e3181e7d626 PMid:20823763 DOI: https://doi.org/10.1097/ALN.0b013e3181e7d626
Pokharel K, Tripathi M, Gupta PK, Bhattarai B, Khatiwada S, Subedi A. Premedication with oral alprazolam and melatonin combination: A comparisonwith either alone-a randomized controlled factorial trial. Biomed Res Int. 2014;2014:356964. https://doi.org/10.1155/2014/356964 PMid:24527443 DOI: https://doi.org/10.1155/2014/356964
Khezri MB, Merate H. The effects of melatonin on anxiety and pain scores of patients, intraocular pressure, and operating conditions during cataract surgery under topical anesthesia. Indian J Ophthalmol. 2013;61(7):319-24. https://doi.org/10.4103/0301-4738.99637 PMid:23552356 DOI: https://doi.org/10.4103/0301-4738.99637
Caumo W, Torres F, Moreira NL Jr., Auzani JA, Monteiro CA, Londero G, et al. The clinical impact of preoperative melatonin on postoperative outcomes in patients undergoing abdominal hysterectomy. Anesth Analg. 2007;105(5):1263-71. https://doi.org/10.1213/01.ane.0000282834.78456.90 PMid:17959953 DOI: https://doi.org/10.1213/01.ane.0000282834.78456.90
Andersen LP, Werner MU, Rosenberg J, Gögenur I. A systematic review of peri-operative melatonin. Anaesthesia. 2014;69(10):1163-71. https://doi.org/10.1111/anae.12717 PMid:24835540 DOI: https://doi.org/10.1111/anae.12717
Hansen M, Halladin N, Rosenberg J, Gögenur I, Møller A. Melatonin for pre-and postoperative anxiety in adults (Review). Cochrane Database Syst Rev. 2015;2015(4):CD009861. https://doi.org/10.1002/14651858.CD009861.pub2 PMid:25856551 DOI: https://doi.org/10.1002/14651858.CD009861.pub2
National Institute for Health and Care Excellence. BNF: British National Formulary-NICE. United Kingdom: National Institute for Health and Care Excellence; 2019. Available from: https://www.bnf.nice.org.uk/treatment-summary/premedication-and-peri-opera tive-drugs Html [Last accessed on 2019 Jun 25].
Johnson K, Page A, Williams H, Wassemer E, Whitehouse W. The use of melatonin as an alternative to sedation in uncooperative children undergoing an MRI examination. Clin Radiol. 2002;57(6):502-6. https://doi.org/10.1053/crad.2001.0923 PMid:12069468 DOI: https://doi.org/10.1053/crad.2001.0923
Impellizzeri P, Vinci E, Gugliandolo MC, Cuzzocrea F, Larcan R, RussoT, et al. Premedication with melatonin vs midazolam: Efficacy on anxiety and compliance in paediatric surgical patients. Eur J Pediatr. 2017;176(7):947-53. https://doi.org/10.1007/s00431-017-2933-9 PMid:28540436 DOI: https://doi.org/10.1007/s00431-017-2933-9
Palmer AC, Souza A, Santos VS, Cavalheiro JA, Schuh F, Zucatto AE, et al. The effects of melatonin on the descending pain inhibitory system and neural plasticity markers in breast cancer patients receiving chemotherapy: Randomized, double-blinded, placebo-controlled trial. Front Pharmacol. 2019;10:1382. https://doi.org/10.3389/fphar.2019.01382 PMid:31824318 DOI: https://doi.org/10.3389/fphar.2019.01382
Lee TY, Curtin JP. The effects of melatonin prophylaxis on sensory recovery and postoperative pain following orthognathic surgery: A triple-blind randomized controlled trial and biochemical analysis. Int J Oral Maxillofac Surg. 2020;49(4):446-53. https://doi.org/10.1016/j.ijom.2019.07.006 PMid:31420120 DOI: https://doi.org/10.1016/j.ijom.2019.07.006
Procaccini DE, Lobner K, Anton B, Kudchadkar SR. Melatonin use in hospitalized children for non-anesthetic indications: A systematic review. Pharmacotherapy. 2020;40(7):692-703. https://doi.org/10.1002/phar.2408 PMid:32342515 DOI: https://doi.org/10.1002/phar.2408
Hemati K, Pourhanifeh MH, Dehdashtian E, Fatemi I, Mehrzadi S, Reiter RJ, et al. Melatonin and morphine: Potential beneficial effects of co-use. Fundam Clin Pharmacol. https://doi.org/10.1111/fcp.12566 PMid:32415694 DOI: https://doi.org/10.1111/fcp.12566
Dubey RK, Srivastava S, Gupta PK. Effect of melatonin premedication on postoperative analgesic requirement in laparoscopic cholecystectomy surgery. IOSR J Pharma. 2017;7(8):10-5.
Ismail SA, Mowafi HA. Melatonin provides anxiolysis, enhances analgesia, decreases intraocular pressure, and promotes better operating conditions during cataract surgery under topical anaesthesia. Anesth Analg. 2009;108(4):1146-51. https://doi.org/10.1213/ane.0b013e3181907ebe PMid:19299777 DOI: https://doi.org/10.1213/ane.0b013e3181907ebe
Borazan H, Tuncer S, Yalcin N, Erol A, Otelcioglu S. Effects of preoperative oral melatonin medication on postoperative analgesia, sleep quality, and sedation in patients undergoing elective prostatectomy: A randomized clinical trial. J Anesth. 2010;24(2):155-60. https://doi.org/10.1007/s00540-010-0891-8 PMid:20186437 DOI: https://doi.org/10.1007/s00540-010-0891-8
Tunay TL, Ilgınel MT, Ünlügenç H, Tunay M, Karacaer F, Biricik E. Comparison of the effects of preoperative melatonin or vitamin C administration postoperative analgesia. Bosn J Basic Med Sci. 2020;20(1):117-24. https://doi.org/10.17305/bjbms.2019.4379 PMid:31465720 DOI: https://doi.org/10.17305/bjbms.2019.4379
Naguib M, Samarkandi AH. Premedication with melatonin: A double-blind, placebo-controlled comparison with midazolam. Br J Anaesth. 1999;82(6):875-80. https://doi.org/10.1093/bja/82.6.875 PMid:10562782 DOI: https://doi.org/10.1093/bja/82.6.875
Acil M, Basgul E, Celiker V, Karagöz AH, Demir B, Aypar U, et al. Perioperative effects of melatonin and midazolam premedication on sedation, orientation, anxiety scores and psychomotor performance. Eur J Anaesthesiol. 2004;21(7):553-7. https://doi.org/10.1017/s0265021504007094 PMid:15318468 DOI: https://doi.org/10.1097/00003643-200407000-00009
Yildiz M, Sahin B, Sahin A. Acute effects of oral melatonin administration on arterial distensibility, as determined by carotid-femoral pulse wave velocity, in healthy young men. Exp Clin Cardiol. 2006;11(4):311-3. PMid:18651024
Scheer FA, van Montfrans GA, van Someren EJ, Mairuhu G, Buijs RM. Daily nighttime melatonin reduces blood pressure in male patients with essential hypertension. Hypertension. 2004;43(2):192-7. https://doi.org/10.1161/01.HYP.0000113293.15186.3b PMid:14732734 DOI: https://doi.org/10.1161/01.HYP.0000113293.15186.3b
Soltani F, Salari A, Javaherforooshzadeh F, Nassajjian N, Kalantari F. The effect of melatonin on reduction in the need for sedative agents and duration of mechanical ventilation in traumatic intracranial hemorrhage patients: A randomized controlled trial. Eur J Trauma Emerg Surg. 2020;48(1):545-51. https://doi.org/10.1007/s00068-020-01449-3 PMid:32699918 DOI: https://doi.org/10.1007/s00068-020-01449-3
Terán F, Medina R, Reyes-Granados V. Synergistic antinociceptive interaction between acetaminophen or metamizol and B vitamins in the formalin test. Drug Dev Res. 2006;66(4):286-94. https://doi.org/10.1002/ddr.20071 DOI: https://doi.org/10.1002/ddr.20071
Mibielli MA, Geller M, Cohen JC, Goldberg SG, Cohen MT, Nunes CP, et al. Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: The DOLOR study. Curr Med Res Opin. 2009;25(11):2589-99. https://doi.org/10.3111/13696990903246911 PMid:19731994 DOI: https://doi.org/10.3111/13696990903246911
Shabayek IA, Abdel-Hamid SM, Elbanna MM. The comparative preemptive analgesic efficacy of addition of Vitamin B complex to gabapentin versus gabapentin alone in orthopedic surgery under spinal anesthesia. Egypt J Hosp Med. 2019;74(1):120-5. https://doi.org/10.21608/EJHM.2019.22640 DOI: https://doi.org/10.21608/ejhm.2019.22640
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