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Study aim
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Dexamethasone plus Ketorolac compare with the Ketorolac alone for the treatment of acute renal colic
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Design
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A permuted block randomization, triple blind and controlled clinical trial, for evaluating anti analgesic effects in renal colic in two groups (60 patients in each group).
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Settings and conduct
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renal colic patients who admitted to the emergency unit of Imam Ali hospital, Bojnurd, randomly admitted to control or intervention groups. They will ask to complete analgesic questionnaire before, 30 and 60 minute after receiving drugs. The study is blinded for both patient and doctor.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
18-60 year old;
Renal colic with severity >5 according visual analogue scale-10 cm.
Non-inclusion criteria:
Pregnancy;
Lactation;
Contraindications for the use of ketorolac(hypersensitivity to aspirin, other nonsteroidal anti-inflammatory drugs, active or history of peptic ulcer disease, recent or history of GI bleeding or perforation or suspected or confirmed cerebrovascular bleeding, advanced hepatic or renal disease or patients at risk for renal failure (CrCl<30 ml/min), hyperkalemia, and severe heart failure; Contraindications for the use of dexamethasone such as (hypersensitivity , systemic fungal infections, liver failure);
Analgesic therapy during 6 hours before admitted to the emergency unit;
History of diathesis;
Near history of addiction or methadone use;
Use of warfarin;
Acute abdomen (Peritonitis);
axillary temperature >37.7;
BP>=18/10 cmHg
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Intervention groups
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Control group: Ketorolac (30 mg, SD, IV) plus Placebo (D.W, 1 CC, IV),
Intervention group : Ketorolac (30 mg, SD, IV) plus Dexamethasone (8 mg, SD, IV),
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Main outcome variables
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Severity of pain