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

University of Monastir

Status and phase: Completed; Phase 1

Conditions: Renal Colic

Treatments: Drug: NM; Drug: IV Serum Saline; Drug: Nebulised Serum Saline; Drug: IV NSAI

Study type: Interventional

Funder types: Other

Identifiers

NCT02156596

NSAI vs Morphine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Intravenous NSAI

Active Comparator group

Description:

patients received 100 mg of ketoprofen (NSAID) by IV root and in parallel 3 nebulisation of serum saline (SS) over 30 minutes.

Treatment:

Drug: IV NSAI

Drug: Nebulised Serum Saline

Nebulised Morphine

Experimental group

Description:

patients received 3 nebulisation of morphine (5 mg each) and in parallel 50 ml of SS by IV root over 30 minutes.

Treatment:

Drug: IV Serum Saline

Drug: NM