Evaluation of novel adhesive film containing ketorolac for post-surgery pain control: a safety and efficacy study.
BACKGROUND
Prescribing analgesics after periodontal surgery is a common practice. However, it can become a challenge for patients with systemic diseases or who are on long-term medications. Ketorolac tromethamine (KT), a non-steroidal anti-inflammatory drug, is incorporated into an adhesive film to overcome the limitations associated with oral, intravenous, intramuscular, or sublingual routes of drug administration. This study evaluates the analgesic effect of a KT adhesive film for pain management after periodontal surgery.


METHODS
Aqueous solvents of two bioadhesive polymers (hydroxypropyl methylcellulose and polyacrylic acid), together with 30 mg of KT, were used to formulate the adhesive film. Sixty-eight patients, who each received a free gingival graft, were randomly divided into treatment and control groups. In the treatment group, the prepared adhesive film was applied over the surgical site, whereas in the control group adhesive film without KT was placed initially. Two hours after surgery, the KT adhesive film was applied on the surgical site in the control group. A visual analog scale was used to assess the degree of pain encountered at 0, 1, 2, 3, 4, 5, 24, and 48 hours post-surgery.


RESULTS
The treatment group reported a significant reduction of pain intensity during the first 2 hours after surgery (P <0.05). After the KT adhesive film was applied in the control group, pain intensity was reduced to a non-significant level by the third hour after surgery. No adverse reaction or undesirable gastrointestinal side effect was observed.


CONCLUSIONS
Adhesive film containing 30 mg of KT was effective in controlling post-surgical pain with no observable gastrointestinal effects.
Eng. A.B. Research Chair for Growth Factors and Bone Regeneration, Division of Periodontics, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.
Khalid
K
Al-Hezaimi
Mansour
M
Al-Askar
Zuied
Z
Selamhe
Jia-Hui
JH
Fu
Ibrahim A
IA
Alsarra
Hom-Lay
HL
Wang
D000180:Acrylic Resins / Q000737:chemistry; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D001704:Biopolymers / Q000737:chemistry; D004311:Double-Blind Method; D004337:Drug Carriers; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D005881:Gingiva / Q000637:transplantation; D005882:Gingival Diseases / Q000601:surgery*; D005889:Gingival Recession / Q000601:surgery; D006801:Humans; D065347:Hypromellose Derivatives; D020911:Ketorolac Tromethamine / Q000008:administration & dosage*; D008297:Male; D008747:Methylcellulose / Q000031:analogs & derivatives / Q000737:chemistry; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D010919:Placebos; D012449:Safety; D016896:Treatment Outcome; D055815:Young Adult
D000180:Acrylic Resins; D000894:Anti-Inflammatory Agents, Non-Steroidal; D001704:Biopolymers; D004337:Drug Carriers; D005782:Gels; D010919:Placebos; D065347:Hypromellose Derivatives; D020911:Ketorolac Tromethamine; C006903:carbopol 940; D008747:Methylcellulose