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Intranasal Tapentadol vs Intravenous Paracetamol for pain in Lower Limb Orthopaedic Surgeries
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November 2024
Intranasal Tapentadol vs Intravenous Paracetamol for pain in Lower Limb Orthopaedic Surgeries
Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:1
Intranasal Tapentadol Versus Intravenous Paracetamol for Postoperative Analgesia in Lower Limb Orthopaedic Surgeries Under Spinal Anaesthesia: A Single Blind RCT.
Clin J Pain . 2024 Aug 1;40(8):463-468.Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
Seventy-four patients undergoing lower limb orthopedic surgeries under spinal anesthesia were randomized to receive either intranasal tapentadol (44.5 mg, n=37) or intravenous paracetamol (1 g, n=37) every 6 hours for 72 hours, starting 3 hours after surgery. The primary outcome was pain intensity measured by the Visual Analog Scale (VAS). Secondary outcomes included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and the need for rescue analgesia. Outcomes were assessed at multiple time points up to 72 hours post-intervention. Overall, the study revealed that intranasal tapentadol resulted in significantly lower pain scores compared to intravenous paracetamol. Additionally, patients in the tapentadol group required no rescue analgesia and exhibited favorable hemodynamic parameters.
Publication Funding Details
Funding
Not Reported
Funding Details
N/A
Disclosures
None disclosed
Why was this study needed now?
Postoperative pain management remains critical in lower limb orthopedic surgeries. Intranasal tapentadol, a novel centrally acting analgesic with dual mechanisms, offers ease of administration and a favorable safety profile compared to intravenous paracetamol, a commonly used analgesic with predictable pharmacokinetics but requiring complex administration. Despite their individual benefits, no direct comparison of these two agents had been made for postoperative pain relief. This study addresses a significant knowledge gap and seeks to determine the superiority of one approach over the other.
What was the principal research question?
In patients undergoing lower limb orthopedic surgeries under spinal anesthesia, does intranasal tapentadol result in better postoperative analgesia compared to intravenous paracetamol over a 72-hour period?
What were the important study characteristics?
Population
74
Total Sample Size
Patients aged 18–60 years undergoing elective lower limb orthopedic surgeries under spinal anesthesia.
Intervention
37
Tapentadol
Mean age: 36.5 years. 24% male.
Received 44.5 mg of intranasal tapentadol spray every 6 hours for 72 hours.
Comparison
37
Paracetamol
Mean age: 36.2 years. 21% male.
Received 1 g of intravenous paracetamol every 6 hours for 72 hours.
Outcomes
Time to offset of spinal anaesthesia
Anaesthesia
Lower = Better
Visual analogue scale (VAS) - pain
Pain
Lower = Better
Scale: 0.0 to 10.0 cm
Systolic Blood Pressure
Vitals
Lower = Better
Diastolic Blood Pressure
Vitals
Lower = Better
Heart Rate
Vitals
Lower = Better
Methods
RCT
Randomized Controlled Trial
Single-Centered
Locations: India
Blinding
Blinded
Who was blinded? Outcome Assessors
Paradigm
Superiority
Time
Baseline
Outcomes: Pain, Vitals
12 Hours
Outcomes: Vitals
12 Years
Outcomes: Pain
24 Hours
Outcomes: Vitals
24 Years
Outcomes: Pain
36 Hours
Outcomes: Vitals
36 Years
Outcomes: Pain
48 Hours
Outcomes: Vitals
48 Years
Outcomes: Pain
60 Hours
Outcomes: Vitals
60 Years
Outcomes: Pain
72 Hours
Outcomes: Vitals
75 Years
Outcomes: Pain
Time to event
Outcomes: Anaesthesia
What were the important findings?
Intranasal tapentadol reduced VAS pain scores more effectively than intravenous paracetamol at all measured time points except 36 hours, with the greatest reduction at 72 hours (p<0.001). A higher proportion of patients in the paracetamol group (21.6%) required rescue analgesia compared to none in the tapentadol group (p=0.003). Hemodynamic parameters (SBP and HR) were significantly lower in the tapentadol group, particularly at 24 and 72 hours (p<0.05).
What should I remember most and how will this affect the care of my patients?
Intranasal tapentadol is superior to intravenous paracetamol for postoperative pain management in lower limb orthopedic surgeries, offering better pain control and reduced need for rescue analgesia. Clinicians should consider its ease of administration and hemodynamic stability when selecting analgesics. However, the study's small sample size and limited adverse effect data are notable limitations.
DISCLAIMER:
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.
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