Comparative Clinical Evaluation of Analgesic Efficacy of Tapentadol Intranasal Spray and Diclofenac Paracetamol Oral Tablet in Post Surgical Mandibular Third Molar Impaction.
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
Study Overview
Brief Summary
KEY ARTICLES :
Md. Khizar Hussain Mazhari, Jagadish Chandra and Joyce P. 2023.
DOI:10.9734/JPRI/2023/v35i87340
conducted a study to evaluate the efficacy of post extraction pain control between Tapentadol nasal spray and oral administration of Diclofenac tablet with bilateral surgical extraction of mandibular 3rd molar. They observed that Tapentadol Intranasal spray has a great efficacy in post extraction pain control as compared with Diclofenac Tablet (50mg).
- Swarbhanu Porel et al, in 2023.
e-ISSN: 0975-5160, p-ISSN: 2820-2651
published a research article on The Effectiveness of Tapentadol in Perioperative Analgesia: A Prospective Comparative Study of Nasal spray and Oral Preparations. Elective laparoscopic cholecystectomies under general anesthesia were carried out in 60 Adults of either sex. They were divided into 2 groups, Each group of 30 individuals.
One group received Intranasal Tapentadol, (Group N–Nasal Tapentadol) and the other group received Oral Tapentadol (Group T -Oral Tapentadol)
They concluded that nasal Tapentadol had better analgesic efficacy and hemodynamic stability as compared to oral formulations.
3)Dr. Sumitoj Singh et al.,2023.
ISSN:0975-3583,0976-2833
conducted a study to compare the efficacy of Tapentadol Nasal Spray and Intramuscular injection Diclofenac sodium as an analgesic for post-operative pain management in patients undergoing various elective and emergency surgeries. They concluded, that mean pain score was less in the Tapentadol nasal spray group as compared to the intramuscular Diclofenac sodium group at all intervals by VAS. (p<0.05).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy patients aged 18 to 45 years of either gender who requires surgical extraction of Impacted mandibular third molar.
- •Patient who are willing to take part in the study.
- •Patient who are free of any systemic disease.
- •Literate/mentally sound/capable of understanding the procedure & VAS to note down the scores.
Exclusion Criteria
- •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.
Investigators
Dr Shweta Gurudatta Rajput
Nair Hospital Dental College