Does Benzydamine hydrochloride oral rinses decrease pain and drug requirement after molar tooth extraction
- Conditions
- Third Molar pathology requiring extraction
- Registration Number
- CTRI/2017/08/009220
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Introduction: Third molar extraction is associated with considerable pain and discomfort. Numerous drugs e.g., NSAIDS, COX 2 inhibitors, opioids have been studied. Pre-emptive analgesia with dexamethasone or local anesthetic infiltration has also been used. Topical application of analgesic drugs have been found to be useful for oral ulcers and post tonsillectomy pain, but it has never been studied for control of pain following third molar extraction. We tried to assess the analgesic effect of Benzydamine hydrochloride, a topical NSAID oral rinse in the control of post operative pain following third molar extraction.
Methodology: A randomized controlled trial was conducted in 40 patients scheduled for fully erupted third molar extraction. They were divided into two groups. Group A- Benzydamine hydrochloride mouth wash and Group B- Normal saline gargle with oral analgesics (Ibuprofen and Paracetamol). Ibuprofen and Paracetamol was the rescue analgesic drug in Group A.
Patients were doing their self evaluation at home while in hospital patients were evaluated on 3rd and 7th post-extraction day. Pain (VAS score), trismus, total number of analgesics consumed and satisfaction level of the patient on Global assessment of pain was recorded.
Results: Intensity of pain (VAS) in group A was more than in group B on the 3rd and 7th post operative day but was statistically insignificant. Analgesics consumed in group A was less than group B on 3rd 7th post operative day and also statistically insignificant. Similarly trismus on 3rd and 7th post operative day had a P value of 0.609 and 0.490 respectively and patient satisfaction level on 3rd and 7th post operative had P values of 0.283 and 0.217respectively.
Conclusion: Use of Benzydamine hydrochloride gargle did result in consumption of less oral analgesics but it had no statistically significant value. Also there were no statistically significant differences in post operative pain scores or satisfaction level between patients using normal saline gargle and those using Benzydamine hydrochloride gargle.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
- Patients 18years and above coming for fully erupted mandibular third molar extraction 2.
- Patients belonging to ASA physical statusI&II.
- 1.Tooth requiring surgical extraction 2.Periodontally weak tooth 3.Tooth associated with peri-apical pathology 4.Tooth associated with fracture 5.Tooth with cellulitis or abscess 6.Tooth where adjacent 2nd molar can be a source of pain- eg.
- caries 7.Patients with other conditions that may alter the healing capacity post-extraction- like diabetes mellitus, those receiving bisphosphonate therapy or post radiotherapy patients 8.Patients with hypersensitivity to NSAIDS, peptic ulcer,GI bleed and myocardial infarction.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Scoring of pain in VAS. 3rd and 7th post operative day- Trismus 3rd and 7th post operative day- Total number of analgesics consumed 3rd and 7th post operative day- Satisfaction level of the patient 3rd and 7th post operative day-
- Secondary Outcome Measures
Name Time Method Pain, Trismus, Analgesic requirement 3rd to 7th Post operative day
Trial Locations
- Locations (1)
All India Institute of Medical Sciences New Delhi
🇮🇳South, DELHI, India
All India Institute of Medical Sciences New Delhi🇮🇳South, DELHI, IndiaDr Devalina GoswamiPrincipal investigator9971196699drdevalina@gmail.com