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Paracetamol Plus Tramadol Versus Fentanyl in Day Case Surgeries

Paracetamol Plus Tramadol Versus Fentanyl as Pre-emptive Analgesia for Enhanced Recovery After Day-Case Surgeries: A Randomised Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05990686
Enrollment
102
Registered
2023-08-14
Start date
2025-06-01
Completion date
2025-12-31
Last updated
2026-09-15

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

Conditions

Post Operative Pain, Preemptive Analgesia

Keywords

Tramadol, Fentanyl, Paracetamol, Pre-emptive analgesia, Enhanced recovery after surgery, Day-case surgery

Brief summary

Postoperative pain is an important problem, especially for day case surgeries. It has negative effects on patient's hemodynamics and can cause delayed ambulation resulting in prolonged duration of hospital stay and poor patient satisfaction. Multiple analgesic strategies have been proposed including NSAID, opioids, epidural analgesia. Each of them has its limitations. In this study the investigators will compare the effect of preemptive use of paracetamol plus tramadol versus preemptive intravenous fentanyl in controlling postoperative pain

Detailed description

After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, non invasive blood pressure and electrocardiogram and baseline parameters will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started. Patients will be randomly allocated into two equal groups: \- Group (T) (n=51): Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and finished before the start of induction of anesthesia \- Group ( F ) (n=51): Intravenous injection of 1.5 microgram/kg fentanyl will be given to the patient before induction. Both groups will be induced with propofol 2 mg/kg and cisatracurium 0.15 mg/kg to facilitate endotracheal intubation and maintained with inhaled isoflurane and incremental doses of muscle relaxant if needed. Neuromuscular blockade will be reversed using neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. In both groups intraoperative monitoring of heart rate (beats/min) and mean arterial blood pressure (mmHg) will be documented. Postoperatively: In the recovery room and in the surgical ward the patient's mean blood pressure and heart rate will be measured and recorded at 1, 2, 4, 6, and 12 hours postoperatively. Also, the postoperative pain assessment for all patients will be done by an anesthesiologist (independent observer) at 1, 2, 4, 6 and 12 hours after surgery based on the visual analog scale (VAS) (a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border). The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. A Quality of Recovery questionnaire (QoR-40) will be administered 24 hours postoperatively by an anaesthesiologist independent of the anaesthetic team and not involved in drug administration. Rescue analgesia (intravenous Ketorolac 30 mg) was administered if tachycardia and/or hypertension occurred postoperatively, defined as an increase in heart rate or blood pressure of more than 25 % from baseline, or if the VAS score was 5 or higher. Time to first request for postoperatiev rescue analgesia will be recorded. Rescue antiemetics (Ondansetron 8 mg) will be given to any patient complaining of nausea and vomiting, occurrence of other side effects including bradycardia or hypotension will be recorded and managed (hypotension defined as a decrease in mean arterial pressure (MAP) of more than 20% of baseline value and planned to be treated with crystalloid infusion and 5 mg bolus of ephedrine. Bradycardia, defined as a heart rate below 50 beats/min, will be managed with atropine 0.2-0.5 mg. Patient satisfaction, postoperative sedation/agitation using the Richmod Agitation-Sedation Scale (RASS), and length of postoperative hospital stay will also be recorded.

Interventions

Patients in Group T received an intravenous infusion of paracetamol (15 mg/kg) with tramadol (1 mg/kg), completed immediately before induction of anaesthesia.

Group F received a single intravenous injection of fentanyl 1.5 µg/kg before induction.

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Patients were blinded to their allocated group. The anaesthesiologist who assessed postoperative VAS and sedation scores and who administered rescue analgesia, antiemetics, or treatment for hypotension and bradycardia was also blinded to group allocation. Only the anaesthetic team in the operating theatre, who administered the study drugs and general anaesthesia, was aware of the allocated group, owing to differences in the volume and appearance of the two regimens.

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients scheduled for day case surgeries. * Patient's age: 21-65 years. * Patients with ASA physical status I, II. * BMI 25 - 30 25-30 kg/m²

Exclusion criteria

* Uncooperative patients * Patients with psychological problems * Patients with liver or renal impairment * Patients with a history of allergy to the drugs used in the study * Patients with chronic pain and current use of analgesic therapy for a pre-existing condition * Patients who did not fulfill the inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Enhanced Recovery ScoreThe QoR-40 was administered 24 hours after the surgery by an anaesthesiologist independent of the anaesthetic team and not involved in drug administration.It will be derived from the 40-item Quality of Recovery questionnaire (QoR-40), which assesses five dimensions of postoperative recovery: emotional state, physical comfort, psychological support, physical independence and pain. Each of the 40 items is scored from 1 (worst) to 5 (best), yielding a total score ranging from 40 to 200.

Secondary

MeasureTime frameDescription
Postoperative pain intensityOn arrival to the recovery room and at 1, 2, 4, 6, and 12 hours postoperatively.It will be assessed using the 10 cm visual analogue scale (VAS; 0 = no pain, 10 = worst pain imaginable) and the patient was instructed to mark along the line which pain intensity is currently being experienced.
Rescue analgesicFrom arrival to the recovery room until the first request for rescue analgesia, assessed up to 24 hours postoperatively.Document the first time for the need of rescue analgesia.
Postoperative sedation/agitationAfter extubation, on arrival to the recovery room and at 10 and 20 minutes after arrival to the recovery room.Will be assessed using the Richmond Agitation-Sedation Scale (RASS).
Mean arterial blood pressureBaseline (preoperatively) and on arrival to the recovery room postoperatively.Compare mean arterial blood pressure (mmHg) between patients in both groups.
Heart RateBaseline (preoperatively) and on arrival to the recovery room postoperatively.Compare the heart rate (beats/min) between patients in both groups.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORMICHAEL A shaker, lecturer

Zagazig University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026