Clinical trial NCT05141344: Effect of Oral Melatonin on Postoperative Analgesia After Thoracotomy in Infants
Official title: The Effect of Pre-emptive Oral Melatonin Versus Placebo on Postoperative Analgesia in Infants After Thoracotomy for Closed Cardiac Surgeries: A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 50 patients will be divided into 2 equal groups
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: total pethidine consumption 24 hours postoperatively.
timeFrame: 24 hours
Secondary outcomes:
measure: the intraoperative fentanyl consumption
timeFrame: 2 hours
measure: Neonatal-Infant pain scale
timeFrame: 4 hours,6 hours,8 hours,12 hours,18 hours, 24 hours postoperatively
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Amany Hassan Saleh
Study officials:
References: