Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol

Kempegowda Institute of Medical Sciences, Bangalore

Status and phase: Completed; Phase 4

Conditions: Lower Limb Fracture

Treatments: Drug: Tapentadol Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05999890

KIMS/IEC/A035/D/2021

Details and patient eligibility

About

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

Full 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

Enrollment: 74 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Tapentadol

Experimental group

Description:

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

Treatment:

Drug: Tapentadol Hydrochloride

Paracetamol

Active Comparator group

Description:

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.

Treatment:

Drug: Tapentadol Hydrochloride