Clinical trial
A Comparative Study Between Intranasal Tapentadol Versus Intravenous Paracetamol for Post-operative Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anaesthesia'
Name
KIMS/IEC/A035/D/2021
Description
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
Trial arms
Trial start
2021-07-05
Estimated PCD
2021-12-30
Trial end
2021-12-30
Status
Completed
Phase
Early phase I
Treatment
Tapentadol Hydrochloride
Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia
Arms:
Paracetamol, Tapentadol
Other names:
Paracetamol
Size
74
Primary endpoint
Pain as measured with Visual analogue scale
Every 12 hours after the intervention till about 72 hours after the intervention
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'It is a single blind randomized controlled trial comparing the intranasal tapentadol with intravenous paracetamol for post operative analgesia', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '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', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 74, 'type': 'ACTUAL'}}
Updated at
2023-08-21
1 organization
1 product
1 indication
Product
TapentadolIndication
Fracture