Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations

NCT01685658 | Withdrawn Phase 4

• 2 other identifiers: LOCAL/2012/PGC-012015-002381-23
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this study was to demonstrate the non-inferiority of intravenous paracetamol relative to intravenous ketoprofen when treating renal colic in an emergency ward. Efficacy is measured by the change in verbal numeric scale (vns) for pain at 30 minutes.

Conditions

Renal Colic; Acute Renal Colic

Outcome Measures

Primary Outcomes (1)

• Change in vns for pain

  Verbal numeric scale ranging from 0 to 10.0.

  baseline to 30 minutes

Secondary Outcomes (30)

• Change in vns for pain

  baseline to 90 minutes

• Quantity of (posology) tramadol administered

  baseline (minute 0)

• Quantity of (posology) tramadol administered

  30 minutes

• Quantity of (posology) tramadol administered

  90 minutes

• Quantity of (posology) tramadol administered

  discharge from emergency ward (estimated max of 24 hours)

Study Arms (2)

Ketaprofen

ACTIVE COMPARATOR

Patients randomized to this arm will receive intravenous ketaprofen when treating renal colic. Intervention: intravenous ketaprofen

Drug: Intravenous ketoprofen

Paracetamol

EXPERIMENTAL

Patients randomized to this arm will receive intravenous paracetamol when treating renal colic. Intervention: intravenous paracetamol

Drug: Intravenous paracetamol

Interventions

Intravenous ketoprofen DRUG

Patients will recieve 100 mg of ketoprofen via slow intravenous perfusion. (100mg of ketoprofen powder for injection dissolved in 100 ml injectable isotonic solution)

Ketaprofen

Intravenous paracetamol DRUG

Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)

Paracetamol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for a telephone interview at week 1
• Patient consulting at the Nîmes University Hospital emergency ward with suspicion of renal colic

You may not qualify if:

• The patient is participating in another study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• The patient has a contraindication for a treatment used in this study
• The patient has an allergy to ketoprofen or paracetamol, a history of gastric or intestinal ulcers, bleeding disorders, history of asthma triggered by taking ketoprofen or substances with similar activity such as other NSAIDs or aspirin
• The patient has a fever or is hemodynamically unstable, oligoanuria
• The patient presents with an initial verbal numeric pain score of 10/10.
• The patient has a history of aneurysm or aortic dissection, history of renal transplantation, history of renal or hepatic insufficiency
• The patient took paracetamol or ketoprofen 4 hours before emergency treatment.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CH d'Alès

Alès, 30103, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Renal Colic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre-Géraud Claret, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 14, 2012
• Study Start: September 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

FR (2)