Postoperative Pain
Conditions
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.
Interventions
DRUGPlacebo
sugar-coated tablets will be given one hour preoperatively
it will be given orally one hour preoperatively
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The drugs will be given by an anesthetist who is not one of the observers to ensure blindness
Intervention model description
50 patients will be divided into 2 equal groups
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total pethidine consumption 24 hours postoperatively. | 24 hours | total dose of pethidine given to the patients over 24 hours postopertively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the intraoperative fentanyl consumption | 2 hours | total fentanyl doses in ug |
| Neonatal-Infant pain scale | 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 |
Countries
Egypt
Outcome results
None listed