A Phase 2 interventional study of Diclofenac sodium and Placebo in Pain, sponsored by Institute of Nephro Urology, Bangalore. Completed at 1 site in India. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-08-28.
Sponsored by Institute of Nephro Urology, Bangalore · Phase 2, Interventional, and Treatment
Double J (DJ) stents are placed following upper urinary tract surgeries. DJ stents are usually removed under local anesthesia using rigid cystoscope. Patients experience a lot of pain during this procedure and also continue to have discomfort during voiding for few days. The use of lignocaine jelly during this procedure is not very effective. Use of diclofenac suppository during flexible cystoscopy has been proven to be effective. This study was done to assess the effect of oral diclofenac in pain relief in patients undergoing DJ stent removal by rigid cystoscopy when compared to placebo and to assess its safety in these patients
Consecutive consenting male patients undergoing DJ stent removal under local anesthesia during 2014-15 were enrolled. Patients were randomized to receive 75 mg oral diclofenac or placebo 1 hour prior to procedure by double blind randomization. Intraurethral 2% lignocaine jelly (25 ml) was used in both groups. Pain during rigid cystoscopy, pain at first void and at 24 hours after cystoscopy was assessed using visual analogue scale [VAS] (0 to 100). Adverse reactions to diclofenac and episodes of acute urinary retention, if any, were assessed.
This is the only study on the registry with Institute of Nephro Urology, Bangalore as lead sponsor.
Counted across the registry records on this site, refreshed daily.
All consecutive consenting male patients aged more than 18 years, undergoing DJ stent removal under local anesthesia (2% Lignocaine jelly) during the study period will be included.
Exclusion Criteria:
Oral diclofenac 75 mg one hour prior to stent removal
Drug: Diclofenac sodium
Placebo one hour prior to stent removal
Drug: Placebo
Diclofenac for pain relief
Also known as: Voveran
Placebo for comparison
Pain
Pain during stent removal, first void and 24 hours after procedure
Time frame: Intraoperative upto 24 hours postoperative
Adverse reactions
Adverse reactions to diclofenac sodium
Time frame: 24 hours
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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