Comparative, randomised and blinded study of the analgesic effectiveness of the pre-procedural regimen of parecoxib and hyoscine butylbromide versus urethral lidocaine gel 2% alone, during the placement of a urinary catheter (double-j stent) without anaesthesia

Comparative, randomised and blinded study of the analgesic effectiveness of the pre-procedural regimen of parecoxib and hyoscine butylbromide versus urethral lidocaine gel 2% alone, during the placement of a urinary catheter (double-j stent) without anaesthesia - AODUS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040342

Enrollment

Registered

2026-05-19

Start date

2025-09-04

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N13.3

Interventions

Group 1: Intervention group (Group A): Patients receive intramuscular parecoxib 40 mg plus intramuscular hyoscine butylbromide 20 mg administered 20 minutes before the procedure. Double-J ureteral ste

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients scheduled for elective or semi-urgent double-J ureteral stent placement or exchange; ability to provide written informed consent; ability to self-report pain on a Visual Analogue Scale.

Exclusion criteria

Exclusion criteria: Chronic pain syndrome or regular use of analgesic or antispasmodic medication; known allergy or contraindication to parecoxib, NSAIDs, or hyoscine butylbromide; active peptic ulcer disease or severe renal impairment; pregnancy or breastfeeding; inability to cooperate with the procedure; prior participation in this study.

Design outcomes

Primary

Measure	Time frame
WHAT: Intra-procedural pain intensity during double-J ureteral stent placement, measured on a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain). WHEN: Immediately upon completion of stent placement. HOW: Patient self-report using a standard 100 mm VAS administered by a by nurse.	—

Secondary

Measure	Time frame
Pain intensity 15 minutes after the procedure (VAS 0–10, patient self-report). 2. Patient satisfaction with the procedure (5-point Likert scale, 1=very dissatisfied, 5=very satisfied). 3. Need for rescue analgesia within 30 minutes post-procedure. 4. Procedural interruption due to patient discomfort. 5. Procedure time (minutes). 6. Fluoroscopy time (seconds). 7. Willingness to repeat the procedure without sedation (yes/no).	—

Measure

Time frame

Pain intensity 15 minutes after the procedure (VAS 0–10, patient self-report). 2. Patient satisfaction with the procedure (5-point Likert scale, 1=very dissatisfied, 5=very satisfied). 3. Need for rescue analgesia within 30 minutes post-procedure. 4. Procedural interruption due to patient discomfort. 5. Procedure time (minutes). 6. Fluoroscopy time (seconds). 7. Willingness to repeat the procedure without sedation (yes/no).

—

Countries

Greece

Contacts

Public ContactChristos Kalaitzis

Department of Urology

ckalaitz@med.duth.gr+302551353000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026