Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment

NCT ID: NCT03865004

Last Updated: 2019-03-06

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-17

Study Completion Date

2018-10-17

Brief Summary

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This randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine for the optimum treatment of renal colic. Combination of IV morphine and paracetamol is as effective and rapid as combination of IV Morphine and IV dexketoprophen for optimum treating of renal colic.

Detailed Description

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Conditions

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Renal Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Paracetamol+Morphine

Intervention Type DRUG

1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously

Dexketoprofen plus Morphine

Intervention Type DRUG

Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously

Placebo plus Morphine

Intervention Type DRUG

100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously

Paracetamol

Group Type ACTIVE_COMPARATOR

Paracetamol+Morphine

Intervention Type DRUG

1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously

Dexketoprofen plus Morphine

Intervention Type DRUG

Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously

Placebo plus Morphine

Intervention Type DRUG

100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously

Dexketoprofene

Group Type ACTIVE_COMPARATOR

Paracetamol+Morphine

Intervention Type DRUG

1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously

Dexketoprofen plus Morphine

Intervention Type DRUG

Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously

Placebo plus Morphine

Intervention Type DRUG

100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously

Interventions

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Paracetamol+Morphine

1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously

Intervention Type DRUG

Dexketoprofen plus Morphine

Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously

Intervention Type DRUG

Placebo plus Morphine

100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously

Intervention Type DRUG

Other Intervention Names

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Parol Arveles SF

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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firatbektas

Identifier Type: -

Identifier Source: org_study_id

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