High performance liquid chromatography determination of dexamethasone in plasma to evaluate its systemic absorption following intra-space pterygomandibular injection of twin-mix (mixture of 2 % lignocaine with 1:200,000 epinephrine and 4 mg dexamethasone): randomized control trial.
OBJECTIVE
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).


CONCLUSIONS
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.
Department of Oral and Maxillofacial Surgery, Peoples College of Dental Sciences and Research Center, People's University, Bhanpur, Bhopal, MP, India. emaildarpan@gmail.com.|Oral and Maxillofacial Surgery, H-3/2, BDA Colony, Lalghati, Airport Road, Bhopal, M.P, 462032, India. emaildarpan@gmail.com.
Darpan
D
Bhargava
Department of Oral Medicine and Maxillofacial Radiology, People's Dental Academy, Bhopal, M.P, India.
Ashwini
A
Deshpande
Department of Oral and Maxillofacial Surgery, Peoples College of Dental Sciences and Research Center, People's University, Bhanpur, Bhopal, MP, India.
Shaji
S
Thomas
Department of Oral and Maxillofacial Surgery, People's Dental Academy, Bhopal, M.P, India.
Yogesh
Y
Sharma
Department of Pharmaceutics, Sri Aurbindo College, Indore, M.P, India.
Piush
P
Khare
Department of Pharmaceutical Chemistry, Ravishankar College of Pharmacy, Bhopal, M.P, India.
Sanjeev Kumar
SK
Sahu
Department of Oral and Maxillofacial Surgery, Peoples College of Dental Sciences and Research Center, People's University, Bhanpur, Bhopal, MP, India.
Suyash
S
Dubey
Department of Oral and Maxillofacial Surgery, Peoples College of Dental Sciences and Research Center, People's University, Bhanpur, Bhopal, MP, India.
Ankit
A
Pandey
Department of Oral and Maxillofacial Surgery, Meenakshi Ammal Dental College and Hospital, Chennai, TN, India.
K
K
Sreekumar
D000328:Adult; D000766:Anesthesia, Dental; D000772:Anesthesia, Local; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003907:Dexamethasone / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D004311:Double-Blind Method; D004338:Drug Combinations; D004837:Epinephrine / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007267:Injections; D008012:Lidocaine / Q000008:administration & dosage*; D008297:Male; D008334:Mandible / Q000187:drug effects; D008964:Molar, Third / Q000601:surgery*; D065568:Oral Mucosal Absorption; D011446:Prospective Studies; D014081:Tooth Extraction; D064232:Visual Analog Scale
D004338:Drug Combinations; D003907:Dexamethasone; D008012:Lidocaine; D004837:Epinephrine
Dexamethasone; Extraction; Oral surgery; Third molar; Transalveolar extraction; Wisdom tooth