Opioid sparing effects of intra-venous paracetamol after Percutaneous Nephrolithotomy: a randomized double blinded controlled trail

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201105166504N1

Enrollment

100

Registered

2011-08-08

Start date

2011-06-14

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

PCNL. Calculus of kidney

Interventions

Intervention 1: Enrolled patients will be randomly allocated to 100 placebo and paracetamol groups using balance blocked randomization method (50 patients in each group). In paracetamol group, each pa

Treatment - Drugs

Enrolled patients will be randomly allocated to 100 placebo and paracetamol groups using balance blocked randomization method (50 patients in each group). In paracetamol group, each patient will rece

In control group: In the control group they will received 100cc of normal saline 30 minutes after extubation and every 8 hours for 24 hours (4 times overall).

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Renal calculi candidate for PCNL; Age between 18 -70 years old; American Society of Anesthesiologists (ASA) risk class I (normal healthy patient)). Exclusion criteria: Pregnancy and lactation; Drug and alcohol abuse; Previous history of any allergy to acetaminophen and opioid; Previous history of hepatic (transaminase exciding two times and more of normal limits) or renal failure (serum creatinine exciding 1.5 mg/dl); Bleeding tendency; Consumption of mono-amino-oxidase inhibitors (MAO inhibitors) or their discontinue over past 2 weeks; Other painful physical conditions which might confound pain assessment; Psychiatric or medical conditions that might impair communication or compliance with the study procedures; Use of NSAIDs or other analgesic drug within 12 h preceding study medications; Age below 18 and above 70 years old

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain score. Timepoint: every 4 hours. Method of measurement: VAS.;Paracetamol dose. Timepoint: every 8 hours. Method of measurement: patient records.	—

Secondary

Measure	Time frame
Pethidine dose. Timepoint: After PCNL surgery. Method of measurement: Patients' records.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMeghdad Tabatabaie

Tehran University of Medical Scince

meghdad58@yahoo.co.uk+98 21 8864 4486

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026