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Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol

NCT05999890 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2023-08-21

No results posted yet for this study

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

Conditions

  • Lower Limb Fracture

Interventions

DRUG

Tapentadol Hydrochloride

Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia

Sponsors & Collaborators

  • Kempegowda Institute of Medical Sciences, Bangalore

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2021-12-30
Completion
2021-12-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05999890 on ClinicalTrials.gov