Effect of Oral Melatonin on Postoperative Analgesia After Thoracotomy in Infants
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Melatonin 3 MG Oral Tablet
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
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.
Sites / Locations
- Amany Hassan Saleh
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
melatonin group
placebo group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
total pethidine consumption 24 hours postoperatively.
total dose of pethidine given to the patients over 24 hours postopertively
Secondary Outcome Measures
the intraoperative fentanyl consumption
total fentanyl doses in ug
Neonatal-Infant pain scale
0 no pain 0-3 mild pain 3-5 moderate pain 5-7 severe pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05141344
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
May 22, 2022 (Actual)
Study Completion Date
June 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
50 patients will be divided into 2 equal groups
Masking
ParticipantCare ProviderInvestigator
Masking Description
The drugs will be given by an anesthetist who is not one of the observers to ensure blindness
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
melatonin group
Arm Type
Active Comparator
Arm Description
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
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Melatonin 3 MG Oral Tablet
Intervention Description
it will be given orally one hour preoperatively
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
sugar-coated tablets will be given one hour preoperatively
Primary Outcome Measure Information:
Title
total pethidine consumption 24 hours postoperatively.
Description
total dose of pethidine given to the patients over 24 hours postopertively
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
the intraoperative fentanyl consumption
Description
total fentanyl doses in ug
Time Frame
2 hours
Title
Neonatal-Infant pain scale
Description
0 no pain 0-3 mild pain 3-5 moderate pain 5-7 severe pain
Time Frame
4 hours,6 hours,8 hours,12 hours,18 hours, 24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Amany Hassan Saleh
City
Giza
ZIP/Postal Code
02
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Oral Melatonin on Postoperative Analgesia After Thoracotomy in Infants
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