Analgesic efficacy of tramadol by route of administration in a clinical model of pain.
The objective of this study was to evaluate the analgesic efficacy produced by tramadol given by two different routes of administration in patients experiencing pain after removal of an impacted mandibular third molar under local anesthesia. A double-blind, randomized, placebo-controlled clinical trial was conducted. Patients were assigned into four groups of treatment, twelve subjects per group: Group A, tramadol 50 mg IM one hr before surgery; group B, tramadol 50 mg into the surgical site; group C, tramadol by both routes of administration, 50 mg IM one hr before surgery plus 50 mg into the surgical site; and group D, control. We evaluated intensity of pain and analgesic consumption as was requested. Demographic characteristics and variables describing the difficulty of the surgical procedure were similar between groups. The duration of the anesthetic effect was significantly longer in the groups where tramadol was injected into the surgical site (215 and 252 min). Administration of systemic and local tramadol (50 mg) suppressed the pain intensity values in comparison to the control group (p < 0.05). Also, tramadol in both routes of administration suppressed the pain intensity values in comparison to all groups (p < 0.05). A significant reduction in the consumption of ketorolac was seen in all treatments as compared to the control group. However, only in the route combination group was a significant reduction in the requirement of acetaminophen observed. Nine patients requiring additional medication were treated with ketorolac 30 mg injected intramuscularly; 2 in the systemic group, 2 in the local group, 4 in the control group and only 1 in the combination group. Adverse events were minimal and similar in all groups.
Pozos-Guillén
Amaury de Jesús
Ade J
Facultad de Estomatologia, Universidad Autónoma de San Luis Potosí, Av. Dr. Manuel Nava #2, Zona Universitaria C.P. apozos@uaslp.mx
Martínez-Rider
Ricardo
R
Aguirre-Bañuelos
Patricia
P
Arellano-Guerrero
Abraham
A
Hoyo-Vadillo
Carlos
C
Pérez-Urizar
José
J
D000082:Acetaminophen / Q000008:administration & dosage / Q000627:therapeutic use; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000627:therapeutic use; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007267:Injections; D007273:Injections, Intramuscular; D020910:Ketorolac / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D008964:Molar, Third / Q000601:surgery; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D014081:Tooth Extraction; D014095:Tooth, Impacted / Q000601:surgery; D014147:Tramadol / Q000008:administration & dosage* / Q000627:therapeutic use*
D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000082:Acetaminophen; D014147:Tramadol; D020910:Ketorolac