Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol

NCT05999890 | Completed Phase 4

• 1 other identifier: KIMS/IEC/A035/D/2021
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain as measured with Visual analogue scale

  The pain rating was done as per a visual analogue scale (VAS) of 0-100 (score 0 = no pain, score 100 - most severe pain). Patients with a VAS score of more than 30, at what is considered as base line, in group A=received IV paracetamol 1gm given every 5-6 hourly and in group B=received intranasal tapentadol 44.5mg nasal spray administered every 5-6 hourly. Patient was assessed for pain by using VAS half an hour after administration and the scores were documented. Pain score were recorded at and after 30 minutes of the intervention in the following time frames - 12hr,24hr,36hr,48hr, 60hr and 72hrs after the baseline intervention (0hr).

  Every 12 hours after the intervention till about 72 hours after the intervention

Secondary Outcomes (1)

• The need for rescue analgesia

  In the first 72 hours after the initiation of the intervention

Study Arms (2)

Tapentadol

EXPERIMENTAL

Tapentadol is a novel, centrally acting analgesic with 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 reduction in some of the typical opioid related adverse effects

Drug: Tapentadol Hydrochloride

Paracetamol

ACTIVE COMPARATOR

Paracetamol is one of the most frequently used analgesic and antipyretic agent, interferes neither with platelet nor kidney functions nor does it present the unwanted side effects of NSAIDS.

Drug: Tapentadol Hydrochloride

Interventions

Tapentadol Hydrochloride DRUG

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

Also known as: Paracetamol

Paracetamol; Tapentadol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status 1 \& 2
• Posted for elective lower limb orthopaedic surgeries

You may not qualify if:

• Sepsis at the site of injection
• Coagulopathy
• Patients with history of renal, hepatic, cardiovascular disease
• Patient on chronic opioid use

Sponsors & Collaborators

• Kempegowda Institute of Medical Sciences, Bangalore: lead

Study Sites (1)

Kempegowda Institute of Medical Sciences

Bangalore, Karnataka, 560004, India

Location

MeSH Terms

Interventions

Tapentadol; Acetaminophen

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor) The assessor of the outcome would measure hemodynamic parameters and severity of the pain at the mentioned time intervals. The assessor was not involved in the randomization / administration of the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: It is a single blind randomized controlled trial comparing the intranasal tapentadol with intravenous paracetamol for post operative analgesia

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: July 5, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)