Amany Hassan Saleh
Giza, 02, Egypt
NCT Number: NCT05141344
Thoracotomy pain is one of the severest pain that should be taken seriously, especially in children. (1) Inadequate postoperative pain management can compromise respiratory function, delay postoperative extubation, increase the cost and delay hospital discharge.
Opioids are the most commonly used analgesics to manage postoperative pain; however, they have many possible unfavorable side effects, such as nausea, vomiting, pruritus, and respiratory depression. (3) Melatonin is an endogenous indoleamine secreted by the pineal gland. It has several important physiological functions, including regulation of the circadian rhythms, modulation of season changes, antioxidant, anti-inflammatory, and anticonvulsant effects. (4)
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Notify Me1 month–18 month
All sexes
Interventional
Phase 1
Giza, 02, Egypt
The analgesic effect of melatonin may be referred to as Gi-coupled melatonin receptors, to Gi-coupled opioid-l-receptors or gamma-aminobutyric acid (GABA) receptors with a consequential reduction in anxiety and pain. (5) Gitto and co-workers(6) hypothesized that melatonin may have beneficial effects as an analgesic effect in preterm newborns that are subject to painful procedures, such as endotracheal intubation and mechanical ventilation without detected side effects. Pro-inflammatory and anti-inflammatory cytokines related to pain were more in the common sedation and analgesia group than in melatonin-treated infants suggesting the use of melatonin as an adjunct analgesic therapy during procedural pain. (6) Therefore Melatonin may be a useful perioperative drug as it does not have any known undesirable serious adverse effects. (7)
To the best of investigators' knowledge, this is the first study investigating the effect of melatonin on postoperative pain scores after thoracotomy in infants.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
it will be given orally one hour preoperatively
sugar-coated tablets will be given one hour preoperatively
Time frame: 24 hours
total dose of pethidine given to the patients over 24 hours postopertively
Time frame: 2 hours
total fentanyl doses in ug
Time frame: 4 hours,6 hours,8 hours,12 hours,18 hours, 24 hours postoperatively
0 no pain 0-3 mild pain 3-5 moderate pain 5-7 severe pain
Cairo University
Other
The Effect of Pre-emptive Oral Melatonin Versus Placebo on Postoperative Analgesia in Infants After Thoracotomy for Closed Cardiac Surgeries: A Randomized Controlled Study.
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