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Comparing PARACETAMOL or TRAMADOL in the treatment of pain due to renal stones in the emergency department.

INTRAVENOUS PARACETAMOL OR TRAMADOL FOR THE TREATMENT OF RENAL COLIC IN THE EMERGENCY DEPARTMENT: A RANDOMIZED CLINICAL TRIAL.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015698
Enrollment
90
Registered
2018-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients coming to emergency department with acute colicky pain either due to renal or ureteric calculi.

Interventions

Intervention1: Paracetamol: Paracetamol 1gm in 100 ml Normal saline is given intravenously over 15 minutes. Paracetamol is a potent agent for analgesia in emergency medicine with both analgesic and a

Sponsors

Department of Emergency Medicine Sri Ramachandra University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between 18 to 60 years of age. 2. Patients presenting with unilateral colicky acute flank pain diagnosed as acute renal colic based on their chief complaint, history, physical examination, past medical history, urinalysis, ultrasonography and CT Scan findings consistent with the diagnosis of renal colic. 3. Patients with a visual analog scale (VAS) pain score of >=40/100.

Exclusion criteria

Exclusion criteria: 1. Patient with an allergy to aspirin, paracetamol, tramadol or any opioid analgesic. 2. Patient with hemodynamic instability. 3. Patient with a fever greater than 38â??C (100.40F). 4. Patient with evidence of peritoneal inflammation. 5. Pregnant patients or those suspected to be pregnant or breastfeeding. 6. Patient with proven or suspected aortic aneurysm or dissection. 7. A patient who have used any analgesic drug up to 6 hours before evaluation. 8. Patients with a history of peptic ulcer disease, asthma, bleeding disorder (including the use of oral anticoagulant). 9. Patient with history of heart failure, renal failure, respiratory failure, liver failure, kidney transplant patients, and opioid addiction.Â

Design outcomes

Primary

MeasureTime frame
The primary outcome is the analgesic efficacy of intravenous, single-dose Paracetamol versus Tramadol, which is a change in visual analog scale (VAS) pain score at 20, 30 and 45 minutes after drug administration.Timepoint: VAS pain score at 20, 30 and 45 minutes after drug administration

Secondary

MeasureTime frame
The secondary outcome is the need for the use of rescue analgesia at 30 and 45 minutes and the presence of at least one adverse event.Timepoint: Need for rescue analgesia at 30 and 45 minutes.

Countries

India

Contacts

Public ContactDr S Jagadeesan

Sri Ramachandra University

drjaga102@gmail.com9444439804

Outcome results

None listed

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