Paracetamol for Catheter Related Bladder Discomfort | NCT01652183 | Trialant

Paracetamol for Catheter Related Bladder Discomfort | NCT01652183 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Control (n=32):iv 1.5 ml/kg 0.9% NaCl	Placebo Comparator		Drug: Placebo
Group Paracetamol(n=32):iv 15mg/kg paracetamol	Active Comparator	The patients were randomly divided into two groups: Group P (Paracetamol group, n=32) received intravenous 15mg/kg paracetamol during the surgery and Group C (Control Group, n=32) received intravenous 1.5 ml/kg 0.9% NaCl solution 30 minutes before the of surgery.At the end of the surgery, all patients had an nephrostomy catheter and the insertion site was infiltrated with 20 ml 0.25% bupivacaine infiltration for postoperative analgesia. Each patient received patient-controlled intravenous analgesia by meperidine (10 mg bolus, 20-minute lock-out, no infusion dose and 4 hour limit) for postoperative analgesia. All patients were planned to receive tenoxicam 20 mg intravenously as a rescue analgesic when visual analogue scale (VAS) was >3.	Drug: intravenous paracetamol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reducing of Catheter related bladder discomfort symptoms	CRBD was evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses) at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours.	CRBD was evaluated at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours

Secondary Outcomes

Measure	Description	Time Frame
Assessment of CRBD symptoms by the evaluation of VAS, sedation scales and hemodynamic findings		at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours.

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18653496	Background	Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008 Oct;101(4):506-10. doi: 10.1093/bja/aen217. Epub 2008 Jul 24.
21277735	Background	Binhas M, Motamed C, Hawajri N, Yiou R, Marty J. Predictors of catheter-related bladder discomfort in the post-anaesthesia care unit. Ann Fr Anesth Reanim. 2011 Feb;30(2):122-5. doi: 10.1016/j.annfar.2010.12.009. Epub 2011 Jan 31.