IV NSAI Versus Nebulized Morphine Analgesia for First-line Renal Colic

Condition(s) targeted: Renal Colic

Intervention: IV NSAI (Drug); NM (Drug); IV Serum Saline (Drug); Nebulised Serum Saline (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Monastir

Official(s) and/or principal investigator(s):
Nouira Semir, Professor, Principal Investigator, Affiliation: University of Monastir

Overall contact:
Semir NOUIRA, Phd, Phone: 73106000, Ext: +216, Email: semir.nouira@rns.tn

The aim of the investigators study was to evaluate the feasibility, efficacy and safety of nebulized morphine compared with non-steroidal anti-inflammatory (NSAI)intravenously in the management of renal colic. Determine the need for systematic outpatient prescription of NSAI.

Official title: Intravenous Treatment With NSAIDs Versus Nebulized Morphine Analgesia for First-line Renal Colic: Randomized Controlled Double-blind Single-center Study.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: efficacity: VAS pain reduction

Secondary outcome:

feasibility of the study: number of patients accepting the adhesion to protocol

safety: side effects of treatment

Detailed description: Renal colic are a frequent cause of consultation in the emergency departement (ED). They count for approximatively 20% of patients presenting to the ED with severe acute onset abdominal pain. For acute treatment of renal colics (RC), guidelines recommend the use of intravenous (IV) non-steroidal anti-inflammatory (NSAI) drugs in association with antalgics like Paracetamol or Morphine. But the NSAID present many inconvenient and cannot be used in some type of patients; that's why the investigators investigated the use of other drugs, such as nebulised morphine, in the ED treatment of renal colics. the NM has the adequacy of being quickest, more practical to use and more tolerated than the IV NSAID. In this study, the investigators aim to assess the feasibility, efficacity and safety of nebulised morphine compared to intravenous NSAID in the treatment of RC.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Over 16 years old

- Consenting to participate in the study

- Diagnosis of renal colic matching flank pain / lumbar fossa sided with dipstick and /

or imaging confirmed the diagnosis

- VAS> 50% at consultation

Exclusion Criteria:

- Inability to assess pain VAS;

- Pregnant or lactating woman;

- Recognized renal disease (glomerular filtration rate <60ml/kg/1. 73m2);

- Known hepatic insufficiency;

- Known or suspected allergy to NSAIDs, morphine

- Peptic ulcer known;

Semir NOUIRA, Phd, Phone: 73106000, Ext: +216, Email: semir.nouira@rns.tn

Hospital of Fattouma Bourguiba, Monastir 5000, Tunisia; Recruiting
SEMIR NOUIRA, PHD, Phone: 73106000, Email: semir.nouira@rns.tn

official department site

Starting date: February 2013
Last updated: June 4, 2014