NCT05999890

Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol

A Comparative Study Between Intranasal Tapentadol Versus Intravenous Paracetamol for Post-operative Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anaesthesia'

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Kempegowda Institute of Medical Sciences, Bangalore · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study was to compare the analgesic efficacy of intranasal tapentadol nasal spray 44.5mg and intravenous paracetamol 1gm during the postoperative period by Visual analog scale(VAS)in patients undergoing lower limb(long bone fractures)orthopedic surgeries. Paracetamol is one of the most frequently used analgesic and antipyretic agents, interferes neither with platelet nor kidney functions nor does it present the unwanted side effects of NSAIDs. Tapentadol is a novel, centrally-acting analgesic with a dual mechanism of action, combining mu-opioid receptor agonism with norepinephrine reuptake inhibition. This dual mode of action is responsible for its opioid-sparing effect, which contributes to a reduction in some of the typical opioid-related adverse effects

Detailed description

Inclusion criteria Age: From 18.00 Year(s) to 60.00 years Gender: Both American Society of Anesthesiologists (ASA) physical status: 1 \& 2, posted for elective lower limb orthopedic surgeries Exclusion criteria 1. Sepsis at the site of injection 2. Coagulopathy 3. Patients with history of renal, hepatic, cardiovascular disease 4. Patient on chronic opioid use Outcome Comparing postoperative analgesia between the groups every 12 hours after the intervention till about 72 hours post intervention. The secondary outcome is to compare the need for the rescue analgesia between the groups

Conditions

• Lower Limb Fracture

Interventions

Type	Name	Description
DRUG	Tapentadol Hydrochloride	Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia

Timeline

• Start date: 2021-07-05
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2023-08-21
• Last updated: 2023-08-21

Locations

1 site across 1 country: India