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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250121064471N2
Enrollment
60
Registered
2026-05-17
Start date
2026-05-19
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Condition 1: Patients undergoing femoral fracture surgery. Condition 2: Patients undergoing femoral fracture surgery. Unspecified fracture of femur Fracture of head and neck of femur

Interventions

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. Th

Sponsors

Saveh University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa Hajimirza

Saveh University of Medical Sciences

mahhajimirza@gmail.com+98 86 4850 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026