Efficacy of Melatonin on post operative pain reduction in patients undergoing Head and Neck cancer surgery under General Anaesthesia- Prospective Randomized double blind controlled study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To compare postoperative pain score (VAS score) up to 24 hours after surgery between melatonin and control group.
Study Overview
Brief Summary
Pain is defined as “An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.†Over the past years, definition of pain has become multidimensional, as it is considered to be not just a sensation, but has also been described by several features such as quality perception, location, intensity, emotional impact and frequency. Melatonin is a neurohormone secreted by the pineal gland; it helps to maintain circadian rhythm of sleep cycle. It has been and is being used in many clinical trials with diffe rent therapeutic approaches. It has sedative, analgesic, anti chronobiotic effects.
Present study plans evaluate the efficacy of preoperative Melatonin on post operative pain reduction and preoperative anxiety reduction in patients undergoing Head and Neck cancer surgery under General Anaesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA I and II.
- •Patient of either sex.
- •Age: 18 years-65 years.
- •Patients posted for head and neck oncological surgery.
Exclusion Criteria
- •Refusal of patient or relatives.
- •Severe uncontrolled systemic diseases (DM/HTN/CAD/Valvular heart disease/Respiratory disease/Neuromuscular disorders/Epilepsy).
- •Allergy to study drug.
- •Patients with a history of chronic use of sedatives or analgesics especially opioids or gabapentanoids.
Outcomes
Primary Outcomes
To compare postoperative pain score (VAS score) up to 24 hours after surgery between melatonin and control group.
Time Frame: At the End of surgery, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, 24 hours after end of surgery
Secondary Outcomes
- Perioperative haemodynamic changes.(Perioperative period.)
- Preoperative anxiety score.(Before start of surgery.)
- Sedation score.(At the End of surgery, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, 24 hours after end of surgery.)
- Neutrophil Lymphocyte Ratio score.(Before and after surgery.)
- Time to first analgesic requirement.(Postoperative period till 24 hours.)