To study effectiveness of Drug Melatonin for pain after surgery, in patients of cancer of head and neck region.

Not Applicable

Completed

• Conditions: Health Condition 1: C060- Malignant neoplasm of cheek mucosaHealth Condition 2: C049- Malignant neoplasm of floor of mouth, unspecifiedHealth Condition 3: C039- Malignant neoplasm of gum, unspecifiedHealth Condition 4: C069- Malignant neoplasm of mouth, unspecifiedHealth Condition 5: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynxHealth Condition 6: C73- Malignant neoplasm of thyroid glandHealth Condition 7: C029- Malignant neoplasm of tongue, unspecified

• Registration Number: CTRI/2022/03/040841
• Lead Sponsor: All India Institute of Medical Sciences Rishikesh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-02-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. ASA I and II.

2. Patient of either sex.

3. Age: 18 years-65 years.

4. Patients posted for head and neck oncological surgery.

Exclusion Criteria

1. Refusal of patient or relatives.

2. Severe uncontrolled systemic diseases (DM/HTN/CAD/Valvular heart

disease/Respiratory disease/Neuromuscular disorders/Epilepsy).

3. Allergy to study drug.

4. Patients with a history of chronic use of sedatives or analgesics especially opioids

or gabapentanoids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare postoperative pain score (VAS score) up to 24 hours after surgery between melatonin and control group.Timepoint: 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 Outcome Measures

Name	Time	Method
eutrophil Lymphocyte Ratio score.Timepoint: Before and after surgery.;Perioperative haemodynamic changes.Timepoint: Perioperative period.;Preoperative anxiety score.Timepoint: Before start of surgery.;Sedation score.Timepoint: 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.;Time to first analgesic requirement.Timepoint: Postoperative period till 24 hours.