Effect of Oral Melatonin on Postoperative Analgesia After Thoracotomy in Infants

NCT05141344 | Completed Phase 1

• 1 other identifier: N-101-2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• total pethidine consumption 24 hours postoperatively.

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

  24 hours

Secondary Outcomes (2)

• the intraoperative fentanyl consumption

  2 hours

• Neonatal-Infant pain scale

  4 hours,6 hours,8 hours,12 hours,18 hours, 24 hours postoperatively

Study Arms (2)

melatonin group

ACTIVE COMPARATOR

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

placebo group

PLACEBO COMPARATOR

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

Interventions

Melatonin 3 MG Oral Tablet DRUG

it will be given orally one hour preoperatively

melatonin group

Placebo DRUG

sugar-coated tablets will be given one hour preoperatively

placebo group

Eligibility Criteria

• Age: 1 Month - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiology( ASA) I, II
• less than 18months.
• males and females.
• scheduled for thoracotomy for closed cardiac surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Amany Hassan Saleh

Giza, 02, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Melatonin; Tablets

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The drugs will be given by an anesthetist who is not one of the observers to ensure blindness
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesia ,surgical intensive care and pain management ,Cairo University

Model Details: 50 patients will be divided into 2 equal groups

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: December 15, 2021
• Primary Completion: May 22, 2022
• Study Completion: June 10, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)