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IRCT20250121064471N2 IRCT 2026-05-17 Saveh University of Medical Sciences Efficacy of Ketamine-Paracetamol versus Fentanyl-Paracetamol versus Paracetamol Monotherapy for Acute Postoperative Pain Management Using Patient-Controlled Analgesia in Patients Undergoing Femoral Fracture Fixation Efficacy of Ketamine-Paracetamol versus Fentanyl-Paracetamol versus Paracetamol Monotherapy for Acute Postoperative Pain Management Using Patient-Controlled Analgesia in Patients Undergoing Femoral Fracture Fixation 2026-05-19 anticipated 60 Recruiting https://irct.ir/trial/89222 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of patients to the groups will be done using stratified block randomization method. Patients will be stratified into four strata based on two variables: age (under 50 years and 50 years and above) and gender. Then, using R software and the blockrand package, a random allocation sequence with variable blocks will be generated for each stratum and placed in sealed, opaque envelopes. An independent observer will allocate eligible patients to one of three groups: intervention (ketamine-paracetamol, fentanyl-paracetamol) or control (paracetamol) based on this sequence. This method, by concealing the allocation sequence, will prevent bias in the group assignment process. It is expected that other potential confounding variables such as duration of surgery and anesthesia, and body mass index will be balanced between the groups due to the randomization process; this will be confirmed by comparing the baseline characteristics of participants at the start of the study, Blinding description: This study is designed as a double-blind trial. The patients, treating physicians, and evaluating nurses will be unaware of the nature and pharmaceutical composition of the contents of the pain pumps. The pumps used will be completely identical in appearance and will only be identified by coded labels (A, B, and C). The key to these codes will be accessible only to the independent person responsible for preparing the medications and the data supervisor. 3 Condition 1: Patients undergoing femoral fracture surgery. Condition 2: Patients undergoing femoral fracture surgery. Intervention 1: First intervention group (fentanyl): In addition to receiving the standard pain control protocol (including paracetamol), this group will also receive fentanyl at a dose of 1 µg/kg. The complete contents of the pump will be prepared in a total volume of 100 mL, and the infusion rate will be 5 mL per hour, similar to the control group. Intervention 2: : Second intervention group (ketamine): In addition to receiving the standard pain control protocol (including paracetamol), this group will also receive ketamine at a dose of 0.3 mg/kg. The complete contents of the pump will be prepared in a total volume of 100 mL, and the infusion rate will be 5 mL per hour, similar to the control group. Intervention 3: This group will receive the standard pain control protocol. The pump contents will include paracetamol at a dose of 10 mg/kg, with the total volume adjusted to 100 mL using normal saline, and will be administered at an infusion rate of 5 mL per hour. No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information available.
public Mahsa Hajimirza
Saveh, Madar Square, beginning of Jomhuri Street, Saveh Faculty of Medical Sciences and Health Services
Saveh Iran (Islamic Republic of) ۳۹۱۹۶۷۶۶۵۱ +98 86 4850 1000 mahhajimirza@gmail.com Saveh University of Medical Sciences scientific Mohammad Saleh Sadri
Saveh, Madar Square, beginning of Jomhuri Street, Saveh Faculty of Medical Sciences and Health Services
Saveh Iran (Islamic Republic of) ۳۹۱۹۶۷۶۶۵۱ +98 86 4850 1000 mahhajimirza@gmail.com Saveh University of Medical Sciences Iran (Islamic Republic of) Patients with ASA physical status class I or II Aged 20 to 50 years Patients undergoing femoral fracture surgery Patients undergoing general anesthesia Provision of written informed consent by the patient to participate in the study Absence of acute visual or hearing impairments that would interfere with the patient's ability to understand instructions or use a patient-controlled analgesia pump No performance of any sensory-neural block during or after the surgery 20 years 50 years Both Substance abuse (opioids), alcohol, or psychotropic drugs Allergy to study medications (ketamine, fentanyl, acetaminophen, etc) Pregnancy or lactation Patient's refusal to continue cooperation in the study Liver dysfunction or elevated liver enzymes History of seizures or psychiatric disorders History of chronic pain or daily analgesic use (more than one week) S72.9 S72.0 Unspecified fracture of femur Fracture of head and neck of femur Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group (fentanyl): In addition to receiving the standard pain control protocol (including paracetamol), this group will also receive fentanyl at a dose of 1 µg/kg. The complete contents of the pump will be prepared in a total volume of 100 mL, and the infusion rate will be 5 mL per hour, similar to the control group. : Second intervention group (ketamine): In addition to receiving the standard pain control protocol (including paracetamol), this group will also receive ketamine at a dose of 0.3 mg/kg. The complete contents of the pump will be prepared in a total volume of 100 mL, and the infusion rate will be 5 mL per hour, similar to the control group This group will receive the standard pain control protocol. The pump contents will include paracetamol at a dose of 10 mg/kg, with the total volume adjusted to 100 mL using normal saline, and will be administered at an infusion rate of 5 mL per hour 1-Pain intensity: The patient's mean pain score will be measured using the Visual Analog Scale (VAS). This scale consists of a 10-centimeter line, with the endpoints labeled from 0 (no pain) to 10 (worst possible pain). Timepoint: The assessment time points include immediately after surgery and at 2, 6, 12, 18, and 24 hours post-surgery. Method of measurement: This scale consists of a 10-centimeter line, with the endpoints labeled from 0 (no pain) to 10 (worst possible pain). Sedation level: A trained nurse will assess and record the patient's sedation level immediately after surgery and at 2, 6, 12, 18, and 24 hours post-surgery using the Ramsay Sedation Scale (which measures sedation from 1: anxious and agitated or restless, to 6: no response to a painful stimulus) by observing the patient's condition. Timepoint: The assessment time points include immediately after surgery and at 2, 6, 12, 18, and 24 hours post-surgery. Method of measurement: will be assessed and recorded using the Ramsay Sedation Scale (ranging from 1: anxious and agitated to 6: no response to a painful stimulus) by observing the patient's condition. Saveh University of Medical Sciences Approved 2026-01-12 Ethics Committee of Saveh University of Medical Sciences The campus building of Saveh University of Medical Sciences is located at the first exit after the General and Revolutionary Courts building on Namaz Boulevard in Saveh Saveh Markazi Iran (Islamic Republic of)