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

Renal Colic Clinical Trial

— NSAIvsNM  

Official title:

Intravenous Treatment With Non Steroidal Anti Inflammatory Drugs (NSAID) Versus Nebulized Morphine (NM) Analgesia for First-line Renal Colic: Randomized Controlled Double-blind Single-center Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156596
• Other study ID #: NSAI vs Morphine
• Status: Completed
• Phase: Phase 1
• Start date: February 2013
• Est. completion date: February 2018

Study information

• Verified date: February 2020
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Colic
• Renal Colic

Intervention

Drug:
• IV NSAI
100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root
• NM
3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)
• IV Serum Saline
50 ml of SS is given by IV root over 30 minutes
• Nebulised Serum Saline
3 nebulisations of 5ml SS each are given over 30 minutes

Locations

Country	Name	City	State
Tunisia	Hospital of Fattouma Bourguiba	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacity: VAS pain reduction	The effectiveness of treatment is defined by a decrease in the intensity of pain corresponding to a decrease of the VAS above 50% at 60 minutes compared to baseline.	5, 15, 30, 45 and 60 minutes
Secondary	feasibility of the study: number of patients accepting the adhesion to protocol	the feasibility is assessed by comparing the number of patients accepting the protocol to the total number of patients consulting for RC; and the number of patients that actually completed the protocol course (if above 50%, the protocol is considered feasable).	at base line and at 60 minutes
Secondary	safety: side effects of treatment	the safety of treatment is evaluated by the occurence of side effects at any time of the protocol.; only major side effects (repeated vomiting, untolerated dizziness, conscience troubles, dyspnea and allergic reaction) are admitted to stop the protocol.	5, 15, 30, 45 and 60 minutes

External Links

•   official department site