Optimal Analgesia in Acute Gastroenteritis

NCT ID: NCT02711241

Last Updated: 2016-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dipyrone

Group Type ACTIVE_COMPARATOR

Dipyrone

Intervention Type DRUG

1 gram by slow IV infusion

Papaverine

Group Type ACTIVE_COMPARATOR

Papaverine

Intervention Type DRUG

80 mg by slow intravenous infusion

Interventions

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Dipyrone

1 gram by slow IV infusion

Intervention Type DRUG

Papaverine

80 mg by slow intravenous infusion

Intervention Type DRUG

Other Intervention Names

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Optalgin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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STALNIKOWICZ-DARVASI RUTH

Professsor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruth Stanikowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadssah Medical Organisation

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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AGE123-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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