A study to evaluate the effect of two doses of oral melatonin on anxiety and pain relief in patients undergoing lower limb surgeries.

A study to evaluate clinical impact of two doses of oral melatonin on preoperative anxiety and postoperative pain relief in patients undergoing orthopaedic surgeries

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/02/023330

Enrollment

Registered

2020-02-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: S729- Unspecified fracture of femur

Interventions

Intervention1: Tablet melatonin 3mg: Patients will be randomly allocated to any of the three groups. Group M3 will receive melatonin 3mg per oral night before and 1 hour before surgery.The anaesthesio

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients of either sex aged between 20-60 years,belonging to ASA physical status 1-111 undergoing lower limb orthopaedic surgeries under spinal anaesthesia and able to understand visual analogue scale.

Exclusion criteria

Exclusion criteria: Patients having contraindication to regional anaesthesia,major renal, hepatic or cardiovascular dysfunction, psychiatric disorders like depression or schizophrenia,known allergy to melatonin,pregnancy,patients undergoing treatment with monoamine oxidase inhibitors, warfarin,language or communication difficulties,patients receiving regular preoperative anxiolytics or sedatives and patients who refuse to participate will not be included in the study

Design outcomes

Primary

Measure	Time frame
1.VAR score for anxiety 2.VAS score for pain.Timepoint: The following will be assessed for all three groups of patients i.e those receiving 3mg,6mg of oral melatonin and placebo for 72 hrs postoperatively.Data will be compiled and appropriate statistical test will be used to analyse the results	—

Secondary

Measure	Time frame
Secondary outcome measure will include time to first request for analgesic, 72 hours paracetamol and diclofenac sodium consumption at 0-6, 6-12, 12-24, 24-48 and 48-72 hours, insomnia score, sedation score, nausea score and any side effects. Requirement of any antiemetics to any patient complaining of nausea will be noted.Timepoint: The following will be assessed for all three groups of patients i.e those receiving 3mg,6mg of oral melatonin and placebo for 72 hrs postoperatively.Data will be compiled and appropriate statistical test will be used to analyse the results.	—

Measure

Time frame

Secondary outcome measure will include time to first request for analgesic, 72 hours paracetamol and diclofenac sodium consumption at 0-6, 6-12, 12-24, 24-48 and 48-72 hours, insomnia score, sedation score, nausea score and any side effects. Requirement of any antiemetics to any patient complaining of nausea will be noted.Timepoint: The following will be assessed for all three groups of patients i.e those receiving 3mg,6mg of oral melatonin and placebo for 72 hrs postoperatively.Data will be compiled and appropriate statistical test will be used to analyse the results.

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Countries

India

Contacts

Public ContactDrNarala Sree Vani

Pt.B.D.Sharma PGIMS,Rohtak

vani.narala@gmail.com8800460497

Outcome results

None listed

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