A Phase 1 interventional study of IV NSAI and NM in Renal Colic, sponsored by University of Monastir. Completed at 1 site in Tunisia. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by University of Monastir · Phase 1, Interventional, and Treatment
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.
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.
148 studies on the registry are indexed under Colic; 21 are open to participants now.
This study's enrollment of 100 is above the median of 88 across 122 interventional studies indexed under Colic.
Browse Colic studies →University of Monastir is the lead sponsor of 112 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root
Also known as: ketoprofen IV
3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)
Also known as: morphine
50 ml of SS is given by IV root over 30 minutes
Also known as: serum saline
3 nebulisations of 5ml SS each are given over 30 minutes
Also known as: serum saline
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.
Time frame: 5, 15, 30, 45 and 60 minutes
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).
Time frame: at base line and at 60 minutes
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.
Time frame: 5, 15, 30, 45 and 60 minutes
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University of Monastir