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

NCT02156596 | Completed Phase 1 DMC

• 1 other identifier: NSAI vs Morphine
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Colic

Keywords

renal colic; nebulised morphine; Intravenous NSAID

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  at base line and at 60 minutes

• safety: side effects of treatment

  5, 15, 30, 45 and 60 minutes

Study Arms (2)

Intravenous NSAI

ACTIVE COMPARATOR

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

Drug: IV NSAI; Drug: Nebulised Serum Saline

Nebulised Morphine

EXPERIMENTAL

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

Drug: NM; Drug: IV Serum Saline

Interventions

IV NSAI DRUG

100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root

Also known as: ketoprofen IV

Intravenous NSAI

NM DRUG

3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)

Also known as: morphine

Nebulised Morphine

IV Serum Saline DRUG

50 ml of SS is given by IV root over 30 minutes

Also known as: serum saline

Nebulised Morphine

Nebulised Serum Saline DRUG

3 nebulisations of 5ml SS each are given over 30 minutes

Also known as: serum saline

Intravenous NSAI

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Hospital of Fattouma Bourguiba

Monastir, 5000, Tunisia

Location

Related Links

• official department site

MeSH Terms

Conditions

Renal Colic

Interventions

Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Nouira Semir, Professor

  University of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 5, 2014
• Study Start: February 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)