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

Comparison of the efficacy of ketamine-paracetamol and fentanyl-paracetamol combination regimens versus paracetamol monotherapy in controlling acute postoperative pain using patient-controlled analgesia in patients undergoing femoral fracture fixation

Randomized, double-blind, parallel-group clinical trial Randomization method: Stratified block randomization based on age and gender, using R software The final sample size was considered 20 patients per group and a total of 60 patients for the three groups

Trained nurses will screen and enroll eligible patients, obtaining written informed consent. An independent observer will perform randomization using sealed envelopes containing codes A, B, and C. The intervention will be administered by the principal investigator or a trained nurse in the recovery room, while a blinded assessor will measure pain (VAS) and sedation (Ramsay Scale) outcomes at designated times.

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

Study groups: three parallel groups (ketamine-paracetamol, fentanyl-paracetamol, paracetamol alone)

1-Pain intensity 2-Sedation level

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

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

No further information available.