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

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

The present study is a double‑blind, parallel‑group, randomized clinical trial (using block randomization) conducted on 120 patients.

In this randomized, double‑blind clinical trial, patients scheduled for femoral fracture repair surgery at Valiasr Hospital in Arak will be randomly allocated, using block randomization, into three groups (A, B, and C). Blinding will be achieved through labeling of the drug containers and coding of the patients, and the study outcomes will ultimately be compared between the groups.

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

Melatonin group: Patients in this group will receive two 3‑mg melatonin tablets (Razak Pharmaceutical Company), totaling 6 mg, one hour before surgery. Gabapentin group: Patients in the gabapentin group will receive two 300‑mg gabapentin capsules (Actoverco Pharmaceutical Company) one hour before surgery. Dronabinol group: Patients in the dronabinol group will receive two 2.5‑mg dronabinol capsules (Roxane, Columbus, Ohio) one hour before surgery.

Pain score, adverse effects, mean arterial pressure, heart rate, SaO₂, Ramsay score

Participants will be assigned to three intervention groups in order of arrival and based on a randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. A block randomization method with blocks of 9 will be used to allocate the samples. Thus, using the block random number generation software, a randomization sequence proportional to the required sample size will be generated for the three groups. Initially, all the cases in which the 3 letters A, B, and C can be arranged together in a block of 9 are performed. Then, a block is randomly selected from the blocks by placement, and the arrangement pattern in that block will be used to allocate the participants. Then this block is placed in the main container and another block will be selected again. All these steps will be performed with a software called Sealed Envelope. Concealment will also be observed using this method. The concept of concealment is to make the assignment of individuals to groups unpredictable. In fact, the researcher will not be able to predict which group the next person will be placed in.

This study will be conducted in a double‑blind design. None of the patients will be aware of the type of medication they receive. The drugs will be administered by the anesthesiologist. Each patient’s medication will be placed in a container and handed to them, without the patient knowing its contents. The assigned intern responsible for outcome recording will also be unaware of the group allocation; patients will be evaluated based on their medical record number, and the collected data will be delivered to the supervising attending physician.

After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.

Access will be from 2026/2/21 to 2029/2/21 for 3 years.

University researchers

Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.

University researchers and university professors can request Dr. Ahmadreza Behrouzi to use the data after contacting the relevant professor via message or email. Dr. Hesamuddin Modiri: Phone: 09183615107 Email: he_modir@arakmu.ac.ir, Address: Valiasr Hospital, Arak, Vice-Chancellor of Hospital Education

Letter writing should be done with professors and universities.