A randomized, double-blind, placebo-controlled study comparing the efficacy and safety of paracetamol, serratiopeptidase, ibuprofen and betamethasone using the dental impaction pain model.
Assessment of postoperative sequelae following the removal of an impacted third molar has been used in clinical pharmacology to evaluate the relative efficacy of various analgesic, anti-inflammatory drugs. This study included 150 patients with impacted lower third molars. They were randomly sorted to receive ibuprofen, paracetamol, betamethasone, serratiopeptidase or placebo. Evaluation of efficacy was made using tape measurement (for swelling), visual analogue scale (for pain evaluation), mouth opening ability and oral temperature. The effect of treatment on hematological parameters, bleeding, wound healing and requirement for rescue medication was also studied. Peak pain scores were observed approximately 5-6 hours after the operation. Betamethasone showed significant analgesic activity from day 1. Ibuprofen and betamethasone were significantly more effective than placebo in reducing swelling. Trismus was least with betamethasone. A significant rise in temperature on the operated side occurred only on day 1 in all the groups. Serratiopeptidase did not showed significant analgesic and anti-inflammatory action. Mild-to-moderate adverse effects were reported.
Chopra
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Department of Pharmacology, Lady Hardinge Medical College, New Delhi, India. drdeeptichopra@yahoo.co.in
Rehan
H S
HS
Mehra
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P
Kakkar
A K
AK
D000082:Acetaminophen / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001623:Betamethasone / Q000627:therapeutic use; D004311:Double-Blind Method; D004487:Edema / Q000188:drug therapy / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D008964:Molar, Third / Q000601:surgery*; D010149:Postoperative Pain / Q000188:drug therapy / Q000517:prevention & control*; D010447:Peptide Hydrolases / Q000627:therapeutic use; D012737:Sex Factors; D018709:Statistics, Nonparametric; D014081:Tooth Extraction / Q000009:adverse effects* / Q000379:methods; D014095:Tooth, Impacted / Q000601:surgery; D016896:Treatment Outcome; D055815:Young Adult
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000082:Acetaminophen; D001623:Betamethasone; D010447:Peptide Hydrolases; C022640:serratiopeptidase; D007052:Ibuprofen