Piroxicam fast‐dissolving dosage form vs diclofenac sodium

Abstract

Objective To assess the possible therapeutic effect of 40 mg sublingual piroxicam (fast‐dissolving dosage form, FDDF) compared with intramuscular 75 mg diclofenac, as a reference drug, on acute renal colic in a randomized, double‐blind controlled clinical trial. Patients and methods Eighty patients were assigned to one of two treatment groups; one received an intramuscular injection with 0.2 mL distilled water and two sublingual tablets of 20 mg piroxicam FDDF, and the other received an intramuscular injection with 75 mg diclofenac sodium and two sublingual tablets of placebo. Pain intensity was evaluated by the patient using a visual analogue scale and by the observers. Vital signs at baseline and 30 min after the administration of the study drugs were also recorded. Results The overall efficacy of the treatment was 81%; nine patients in the piroxicam and six in the diclofenac group (no significant difference) required rescue treatment. Compared with baseline levels, the pain relief was significant (P<0.001) at 30 min in both groups. Twenty‐two patients in the piroxicam and 25 in the diclofenac group attained complete pain relief at 30 min, as evaluated by the observer (no significant difference). Both treatments were similarly effective in decreasing vital signs, mainly systolic blood pressure, heart and respiratory rates. However, when the percentage change was compared between the groups, piroxicam significantly decreased the respiratory rate (P<0.03). Conclusion Piroxicam FDDF is as effective as parenteral diclofenac in emergency renal colic treatment. Furthermore, its ease of self‐administration increases patient compliance and potential use in general practice.

A Prospective, Randomised Clinical Trial Comparing Oral Diclofenac Potassium and Intramuscular Diclofenac Sodium in Acute Pain Relief

“…This study showed that either Voltaren ® or Cataflam ® was effective for pain relief with time. (P<0.0001) This was consistent with the results of other studies for patients with renal colic, [4][5][6][7][8][9][10][11] musculoskeletal injuries, [14][15][16][17][18][19][20][21] and arthritis. 25,26 Systolic blood pressure and pulse rate, which would be influenced by the stress of pain, also showed statistically significant reduction with time.…”

“…In patients with renal colic, various clinical trials have demonstrated that NSAID are at least comparable to and frequently superior to many narcotics and spasmolytic combinations. [4][5][6][7][8][9][10][11] For patients with musculoskeletal pain such as back pain, soft tissue injury, joint injury and arthritis, NSAID have also been shown to be effective and well tolerated analgesics. [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] However, there is no international standard on the route of NSAID use; both parenteral and oral (PO) routes are used for acute pain relief.…”

Renal Colic: Pathophysiology, Diagnosis and Treatment

“…Many studies have documented the effectiveness of NSAIDs in the treatment of renal colic [36, 37, 38, 39, 40, 41, 42]. NSAIDs do not have the addictive potential of narcotics, yet provide the same degree of pain relief in some clinical settings.…”

“…A randomized clinical trial evaluated the efficacy of indomethacin, 100 mg rectally, versus 50 mg of the same drug given intravenously and showed that the rectal route was less effective than the intravenous route [41]. In a recent study, Supervia et al [42]compared the therapeutic effect of 40 mg sublingual piroxicam with intramuscular 75 mg diclofenac, as a reference drug, on acute renal colic in a randomized double–blind controlled clinical trial. They concluded that sublingual piroxicam is as effective as parenteral diclofenac in emergency renal colic treatment.…”

“…They concluded that sublingual piroxicam is as effective as parenteral diclofenac in emergency renal colic treatment. Furthermore, its ease of self–administration increases patient compliance and potential use in general practice [42]. …”