Darpan Bhargava1,2, Ashwini Deshpande3, Shaji Thomas4, Yogesh Sharma5, Piush Khare6, Sanjeev Kumar Sahu7, Suyash Dubey4, Ankit Pandey4, K Sreekumar8. 1. Department of Oral and Maxillofacial Surgery, Peoples College of Dental Sciences and Research Center, People's University, Bhanpur, Bhopal, MP, India. emaildarpan@gmail.com. 2. Oral and Maxillofacial Surgery, H-3/2, BDA Colony, Lalghati, Airport Road, Bhopal, M.P, 462032, India. emaildarpan@gmail.com. 3. Department of Oral Medicine and Maxillofacial Radiology, People's Dental Academy, Bhopal, M.P, India. 4. Department of Oral and Maxillofacial Surgery, Peoples College of Dental Sciences and Research Center, People's University, Bhanpur, Bhopal, MP, India. 5. Department of Oral and Maxillofacial Surgery, People's Dental Academy, Bhopal, M.P, India. 6. Department of Pharmaceutics, Sri Aurbindo College, Indore, M.P, India. 7. Department of Pharmaceutical Chemistry, Ravishankar College of Pharmacy, Bhopal, M.P, India. 8. Department of Oral and Maxillofacial Surgery, Meenakshi Ammal Dental College and Hospital, Chennai, TN, India.
Abstract
PURPOSE: To determine systemic absorption of dexamethasone by detection of plasma concentration using high performance liquid chromatography following its administration along with local anesthetic agent as a mixture via pterygomandibular space. METHODS: A prospective randomized double-blind clinical study was undertaken to analyze the plasma concentration of dexamethasone after intra-space pterygomandibular injection along with local anesthesia. The study was performed as per split mouth model where the mandibular quadrant allocation was done on a random basis considering each of the 30 patients is included in the two study interventions (SS and CS). For the study site (SS) procedures, dexamethasone was administered as a mixture (2 % lignocaine with 1:200,000 epinephrine and 4 mg dexamethasone) intra-space. In the control site (CS) procedures, a regular standard inferior alveolar nerve block was administered, and dexamethasone was given as intramuscular injection. The plasma dexamethasone determination was done in venous blood 30- and 60-min post injection using high performance liquid chromatography (HPLC). The clinical parameters like pain; swelling; and mouth opening on the first, third, and seventh post-operative day were analyzed and compared. RESULTS: No significant difference was found in the clinical parameters assessed; comparative evaluation showed less swelling in the SS interventions. The plasma concentration of dexamethasone for the CS interventions was 226 ± 47 ng/ml at 30-min and 316 ± 81.6 ng/ml at 60-min post injection, and for SS, it was 221 ± 81.6 ng/ml at 30-min and 340 ± 105 ng/ml at 60-min post injection. On inter-site (CS and SS) comparison, no statistically significant difference was ascertained in dexamethasone plasma concentration at 30-min post injection (P = 0.77) and at 60-min post injection. (P = 0.32). CONCLUSION:Intra-space (pterygomandibular space) administration of dexamethasone can achieve statistically similar plasma concentration of the drug as when the same dose is administered intramuscularly with demonstration of similar clinical effects.
RCT Entities:
PURPOSE: To determine systemic absorption of dexamethasone by detection of plasma concentration using high performance liquid chromatography following its administration along with local anesthetic agent as a mixture via pterygomandibular space. METHODS: A prospective randomized double-blind clinical study was undertaken to analyze the plasma concentration of dexamethasone after intra-space pterygomandibular injection along with local anesthesia. The study was performed as per split mouth model where the mandibular quadrant allocation was done on a random basis considering each of the 30 patients is included in the two study interventions (SS and CS). For the study site (SS) procedures, dexamethasone was administered as a mixture (2 % lignocaine with 1:200,000 epinephrine and 4 mg dexamethasone) intra-space. In the control site (CS) procedures, a regular standard inferior alveolar nerve block was administered, and dexamethasone was given as intramuscular injection. The plasma dexamethasone determination was done in venous blood 30- and 60-min post injection using high performance liquid chromatography (HPLC). The clinical parameters like pain; swelling; and mouth opening on the first, third, and seventh post-operative day were analyzed and compared. RESULTS: No significant difference was found in the clinical parameters assessed; comparative evaluation showed less swelling in the SS interventions. The plasma concentration of dexamethasone for the CS interventions was 226 ± 47 ng/ml at 30-min and 316 ± 81.6 ng/ml at 60-min post injection, and for SS, it was 221 ± 81.6 ng/ml at 30-min and 340 ± 105 ng/ml at 60-min post injection. On inter-site (CS and SS) comparison, no statistically significant difference was ascertained in dexamethasone plasma concentration at 30-min post injection (P = 0.77) and at 60-min post injection. (P = 0.32). CONCLUSION: Intra-space (pterygomandibular space) administration of dexamethasone can achieve statistically similar plasma concentration of the drug as when the same dose is administered intramuscularly with demonstration of similar clinical effects.
Authors: Paul S Tiwana; Susan P Foy; Daniel A Shugars; Robert D Marciani; Shawn M Conrad; Ceib Phillips; Raymond P White Journal: J Oral Maxillofac Surg Date: 2005-01 Impact factor: 1.895