FindTrial
Sign In

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

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/040841
Enrollment
40
Registered
2022-03-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C060- Malignant neoplasm of cheek mucosa Health Condition 2: C049- Malignant neoplasm of floor of mouth, unspecified Health Condition 3: C039- Malignant neoplasm of gum, unspecified Health Condition 4: C069- Malignant neoplasm of mouth, unspecified Health Condition 5: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Health Condition 6: C73- Malignant neoplasm of thyroid gland Health Condition 7: C029- Malignant neoplasm of tongue, unspecified

Interventions

Intervention1: Oral Tablet Melatonin 9mg.: Oral Tablet Melatonin 9mg, in evening of day before surgery and on morning of surgery Control Intervention1: Oral Tablet of placebo.: Oral Tablet of pkacebo,

Sponsors

All India Institute of Medical Sciences Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Neutrophil 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.—

Countries

India

Contacts

Public ContactAjit Kumar

All India Institute of Medical Sciences, Rishikesh.

Ajitdr.ajit@gmail.com9910789377

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026