Effect of Oral Melatonin on Postoperative Analgesia After Thoracotomy in Infants

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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The Effect of Pre-emptive Oral Melatonin Versus Placebo on Postoperative Analgesia in Infants After Thoracotomy for Closed Cardiac Surgeries: A Randomized Controlled Study.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Melatonin 3 MG Oral Tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology( ASA) I, II less than 18months. males and females. scheduled for thoracotomy for closed cardiac surgery. Exclusion Criteria: airway abnormalities. heart failure. endocrine disorders. Patients with hypersensitivity to any drug. beta blockers, any analgesics recieved within 24 h before surgery, or any psychotropic drugs. hepatic, renal diseases neuromuscular disease, coagulopathy. a history of hyperthermia. infection at the site of the block.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 50 patients will be divided into 2 equal groups
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: melatonin group<br>patients in this group will be premedicated One hour before the start of surgery by receiving 0.5mg/kg orally of melatonin (Melatonin 3 mg ), (the tablet will be dissolved in 5 ml of water, to be given by syringe 5ml) in the preoperative unit | Drug: Melatonin 3 MG Oral Tablet<br>* it will be given orally one hour preoperatively<br>|
| Placebo Comparator: placebo group<br>patients in group P (n =25 ) will receive a placebo( sugary tablets dissolved in 5ml of water by syringe 5 ml) one hour before the start of surgery. | Drug: Placebo<br>* sugar-coated tablets will be given one hour preoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total pethidine consumption 24 hours postoperatively. | total dose of pethidine given to the patients over 24 hours postopertively | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the intraoperative fentanyl consumption | total fentanyl doses in ug | 2 hours | 
| Neonatal-Infant pain scale | 0 no pain 0-3 mild pain 3-5 moderate pain 5-7 severe pain | 4 hours,6 hours,8 hours,12 hours,18 hours, 24 hours postoperatively |