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NCT Number: NCT05141344

Effect of Oral Melatonin on Postoperative Analgesia After Thoracotomy in Infants

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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Key information

Age range

1 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Amany Hassan Saleh

Giza, 02, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin 3 MG Oral Tablet

Drug

it will be given orally one hour preoperatively

Placebo

Drug

sugar-coated tablets will be given one hour preoperatively

Primary outcomes

  1. total pethidine consumption 24 hours postoperatively.

    Time frame: 24 hours

    total dose of pethidine given to the patients over 24 hours postopertively

Secondary outcomes

  1. the intraoperative fentanyl consumption

    Time frame: 2 hours

    total fentanyl doses in ug

  2. Neonatal-Infant pain scale

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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