Pain control after femoral fracture surgery with melatonin, gabapentin, and dronabinol.

Comparison of melatonin, gabapentin and dranabinol in pain control of patients after hip fracture repair surgery.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191104045328N44

Enrollment

120

Registered

2025-10-08

Start date

2025-10-17

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Femur fracture repair surgery. Fracture of shaft of femur

Interventions

Intervention 1: Intervention group: Patients in this group will receive two 3-mg melatonin tablets (Razak Pharmaceutical Co.), totaling 6 mg, one hour prior to surgery. Intervention 2: Intervention gr

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients undergoing surgical repair of femoral fracture. Having informed consent to participate in the study. Performing surgery on one side

Exclusion criteria

Exclusion criteria: Having systemic diseases including kidney, liver, cardiovascular, high blood pressure, diabetes, or malignancy. Having a history of drug or chronic pain medication use. Known hypersensitivity to the studied drugs and presence of seasonal allergy.

Design outcomes

Primary

Measure	Time frame
Pain score. Timepoint: Upon arrival to the operating room, and at 2, 4, 6, 12, and 24 hours post-operatively. Method of measurement: Visual Analog Scale.;Ramsey Score. Timepoint: Upon arrival to the operating room, and at 2, 4, 6, 12, and 24 hours post-operatively. Method of measurement: By registering the Ramsey Score.;Side effects. Timepoint: After the intervention. Method of measurement: History and examination.;Opioid dosage. Timepoint: 24 hours after surgery. Method of measurement: Patient file.	—

Measure

Time frame

Pain score. Timepoint: Upon arrival to the operating room, and at 2, 4, 6, 12, and 24 hours post-operatively. Method of measurement: Visual Analog Scale.;Ramsey Score. Timepoint: Upon arrival to the operating room, and at 2, 4, 6, 12, and 24 hours post-operatively. Method of measurement: By registering the Ramsey Score.;Side effects. Timepoint: After the intervention. Method of measurement: History and examination.;Opioid dosage. Timepoint: 24 hours after surgery. Method of measurement: Patient file.

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Secondary

Measure	Time frame
Mean arterial pressure. Timepoint: At the beginning of surgery, every 15 minutes intra-operatively until the end of surgery, in the recovery room, and at 2 and 4 hours post-operatively. Method of measurement: NIBP monitoring device.;Heart rate. Timepoint: At the beginning of surgery, every 15 minutes intra-operatively until the end of surgery, in the recovery room, and at 2 and 4 hours post-operatively. Method of measurement: Cardiac monitoring device.;Arterial blood oxygen saturation. Timepoint: At the beginning of surgery, every 15 minutes intra-operatively until the end of surgery, in the recovery room, and at 2 and 4 hours post-operatively. Method of measurement: Pulse oximetry.	—

Measure

Time frame

Mean arterial pressure. Timepoint: At the beginning of surgery, every 15 minutes intra-operatively until the end of surgery, in the recovery room, and at 2 and 4 hours post-operatively. Method of measurement: NIBP monitoring device.;Heart rate. Timepoint: At the beginning of surgery, every 15 minutes intra-operatively until the end of surgery, in the recovery room, and at 2 and 4 hours post-operatively. Method of measurement: Cardiac monitoring device.;Arterial blood oxygen saturation. Timepoint: At the beginning of surgery, every 15 minutes intra-operatively until the end of surgery, in the recovery room, and at 2 and 4 hours post-operatively. Method of measurement: Pulse oximetry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Esmaeil Moshiri

Arak University of Medical Sciences

dr_moshiri@arakmu.ac.ir+98 86 3222 2003

Outcome results

None listed

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