Effect of Oral Melatonin on Postoperative Analgesia After Thoracotomy in Infants

Postoperative Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05141344
• Other study ID #: N-101-2021
• Status: Completed
• Phase: Phase 1
• Start date: December 15, 2021
• Est. completion date: June 10, 2022

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 10, 2022
• Est. primary completion date: May 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Months

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Melatonin 3 MG Oral Tablet
it will be given orally one hour preoperatively
• Placebo
sugar-coated tablets will be given one hour preoperatively

Locations

Country	Name	City	State
Egypt	Amany Hassan Saleh	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total pethidine consumption 24 hours postoperatively.	total dose of pethidine given to the patients over 24 hours postopertively	24 hours
Secondary	the intraoperative fentanyl consumption	total fentanyl doses in ug	2 hours
Secondary	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