Back to resultsOptimal Analgesia in Acute Gastroenteritis
Primary Purpose
Gastroenteritis
Status
Terminated
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Dipyrone
Papaverine
Sponsored by
About this trial
This is an interventional treatment trial for Gastroenteritis focused on measuring Gastroenteritis, Analgesia, Emergency department
Eligibility Criteria
Inclusion Criteria:
- acute gastroenteritis
- VAS scale of pain perception at least 4
Exclusion Criteria:
- pregnancy
- allergy to any one of study preparations
- blood pressure less than 85 on admission
- surgical condition (acute abdomen) suspected or diagnosed
Sites / Locations
- Hadssah Medical Organisation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dipyrone
Papaverine
Arm Description
Outcomes
Primary Outcome Measures
Change in pain assessment (VAS) as opposed the pain assessment on admission
Secondary Outcome Measures
Need for second analgesic medicine
Full Information
NCT ID
NCT02711241
First Posted
March 1, 2011
Last Updated
March 13, 2016
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT02711241
Brief Title
Optimal Analgesia in Acute Gastroenteritis
Official Title
Optimal Analgesia in Acute Gastroenteritis in Emergency Department Setting: Dipyrone Versus Papaverine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Not enough patients
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to find out an optimal way of analgesia in case of acute infectious gastroenteritis the investigators are going to compare two medicines that are used on everyday basis (without being ever before subject to scientifical study): Dipyrone and papaverine The study is done in the Emergency Department setting. Thus, only first 6 hours of treatment is included in study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis
Keywords
Gastroenteritis, Analgesia, Emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dipyrone
Arm Type
Active Comparator
Arm Title
Papaverine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dipyrone
Other Intervention Name(s)
Optalgin
Intervention Description
1 gram by slow IV infusion
Intervention Type
Drug
Intervention Name(s)
Papaverine
Intervention Description
80 mg by slow intravenous infusion
Primary Outcome Measure Information:
Title
Change in pain assessment (VAS) as opposed the pain assessment on admission
Time Frame
30 min, 1 hour, 2 hours, on discharge (up to 24 hours)
Secondary Outcome Measure Information:
Title
Need for second analgesic medicine
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute gastroenteritis
VAS scale of pain perception at least 4
Exclusion Criteria:
pregnancy
allergy to any one of study preparations
blood pressure less than 85 on admission
surgical condition (acute abdomen) suspected or diagnosed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Stanikowitz, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadssah Medical Organisation
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Optimal Analgesia in Acute Gastroenteritis
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