A pilot study of the effect of diclofenac with B vitamins for the treatment of acute pain following lower-limb fracture and surgery.
The aim of this pilot study was to compare the efficacy and tolerability of the non-steroidal anti-inflammatory drug (NSAID), diclofenac (2-(2,6-dichloranilino) phenylacetic acid), for treatment of acute pain originated by lower-limb fracture and surgery, with that of diclofenac plus B vitamins. This clinical trial was single-center, prospective randomized and double-blinded. After giving informed consent, patients with lower-limb closed fractures rated their pain on a 10-cm visual analog scale (VAS). Patients were then randomized to receive 75 mg diclofenac or 75 mg diclofenac plus B vitamins (thiamine, pyridoxine and cyanocobalamin) twice daily (all intramuscularly). Patient evaluations of pain intensity were recorded throughout two periods: twenty-four hours pre-surgically and twenty-four hours postsurgical. Twenty-four hours after the first drug administration, patients underwent elective lower-limb surgery. Standardized general anesthetic techniques were used for all patients. Fourteen patients completed the study. The subjects' assessments of limb pain on the visual analog scale showed a significant reduction from baseline values regardless of the treatment group when surveyed at 12, 24, 36 and 48 hr post operation. All treatments showed a similar profile in pain reduction. There were reports of pain in the administration site, but in general, all the regimens were well tolerated.
Garza
Alexis F
AF
Hospital General de los Servicios de Salud del Estado de Hidalgo, Pachuca, Hidalgo, México.
Monroy-Maya
Raúl
R
Soto-Ríos
Marisela
M
Reyes-García
Gerardo
G
Carrillo-Alarcón
Lourdes
L
Ponce-Monter
Héctor
H
Rangel-Flores
Eduardo
E
Ortiz
Mario I
MI
D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D005596:Fractures, Closed / Q000601:surgery*; D006801:Humans; D007273:Injections, Intramuscular; D035002:Lower Extremity / Q000293:injuries* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy*; D010865:Pilot Projects; D014803:Vitamin B Complex / Q000008:administration & dosage* / Q000009:adverse effects
D000894:Anti-Inflammatory Agents, Non-Steroidal; D014803:Vitamin B Complex; D004008:Diclofenac