None listed
Conditions
Interventions
Intervention1: Tapentadol Intranasal Spray: Tapentadol is a novel, centrally acting synthetic opioid analgesic with two mechanisms of action that confers broad efficacy, as demonstrated in a variety o
Sponsors
Dr Shweta Gurudatta Rajput
Eligibility
Inclusion criteria
Inclusion criteria: 1)Healthy patients aged 18 to 45 years of either gender who requires surgical extraction of Impacted mandibular third molar. 2)Patient who are willing to take part in the study. 3)Patient who are free of any systemic disease. 4)Literate/mentally sound/capable of understanding the procedure & VAS to note down the scores.
Exclusion criteria
Exclusion criteria: 1)Patient who may be allergic or hypersensitive to local anaesthesia, study drugs, and medications such as antibiotics and anti-inflammatory treatment. 2)Patient who are in poor health conditions including Cardiac disorders, Diabetes, Hepatitis, Blood disorders, G.I Bleeding or ulcers, Chronic Kidney disorders. 3)Patient with mental illness, Pregnant women and lactating mothers. 4)Patient receiving corticosteroids treatment. 5)Patient with conditions like OSMF, Hypoplastic mandible that may lead smaller mouth opening. 6)Patient with underlying nasal pathology viz rhinitis, polyps, and deviated nasal septum. 7)Patients with respiratory depression or conditions that compromise respiratory function (e.g., chronic obstructive pulmonary disease, severe asthma) 8)Individuals with a history of substance abuse / addiction or Alcoholics. 9)Patients taking medications for neurological and psychiatric disorders e.g. - Antidepressants: Monoamine Oxidase Inhibitors (MAOIs), Selective Serotonin receptor inhibitors. - Antipsychotics: Quetiapine, Olanzapine - Benzodiazepines, Gabapentin, Pregabalin - Muscle relaxants: Cyclobenzaprine, Methocarbamol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative pain intensity measured using the Visual Analogue Scale (VAS) to compare the analgesic efficacy of Tapentadol intranasal spray and Diclofenac-Paracetamol oral tabletTimepoint: Comparison of post-operative pain intensity between Tapentadol intranasal spray and Diclofenac-Paracetamol oral tablet using the Visual Analogue Scale (VAS) at 1, 2, 4, 6, 12, and 24 hours after mandibular third molar dis-impaction surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effects of Tapentadol Intranasal spray & Diclofenac Paracetamol Oral tablet in managing swelling following mandibular third molar surgery.Timepoint: Swelling is measured for both the groups pre-operative, Day1, Day 3 & Day 7;To compare the effects of Tapentadol Intranasal spray & Diclofenac Paracetamol Oral tablet in managing oral opening (trismus) following mandibular third molar surgery.Timepoint: Oral opening (trismus) is measured in both the groups pre operative, Day 1, Day 3 & Day 7. | — |
Countries
India
Contacts
Public ContactDr Snehal N Ingole
Nair Hospital Dental College
Outcome results
None listed