None listed
Conditions
Brief summary
Sildenafil, a phosphodiesterase-5 inhibitor, was reported to have a strong inhibitory effect on contraction of visceral smooth muscle of the gallbladder and to significantly decrease the basal biliary pressure of the Sphincter of Oddi. We hypothesized that a single oral dose of sildenafil given during the acute attack of biliary colic, might counteract the smooth muscular spasm and probably might decrease the pressure inside the ducts and sphincter of Oddi to relieve pain and facilitate release of impacted stones. We conducted a pilot, randomized, single-blind, comparative clinical study to assess the pain relieving effect of a single-dose of 25 mg oral Sildenafil tablet in comparison with a single oral 20 mg ketorolac dose in adult patients presenting with acute biliary colic. Methods: Twenty consecutive eligible patients presenting with moderate to severe biliary colic were randomly assigned to receive one Sildenafil 25 mg tablet or two ketorolac 10 mg oral tablets. A four points verbal rating scale (VRS) and 100 mm Visual pain analog scale (VPAS) of pain severity were measured at baseline before treatment then at 30 and 60 minutes after the intake of the oral dose.
Interventions
sildenafil 25 mg tablet taken orally just once under the direct observation of the investigator, after inclusion of each eligible patient.
Adherence to treatment was monitored for all patients by direct observation and mouth check,
Sponsors
Mostafa Yakoot
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
adult of any sex, aged between 18 and 50 years old experiencing self-described moderate to severe pain in the epigastrium or right upper quadrant of the abdomen that the treating emergency physician suspected to be biliary colic, plus evidence of gallstones, including a known case record of cholelithiasis or immediate abdominal ultrasound examination showing visible stone(s).
Exclusion criteria
pregnancy or breast-feeding; history of coronary artery disease or other cardiac disease with hemodynamic instability or fragility; history of intake of any preparation containing nitrates in any dosage form within the past one week; history of allergy to ketorolac, acetylsalicylic acid (ASA) or another NSAID; and history of peptic ulcer disease, gastrointestinal bleeding, perforation, or inflammatory bowel disease; history or evidence of renal or hepatic dysfunctions..
Outcome results
None listed