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Clinical Trials/NCT01586299
NCT01586299UnknownNot Applicable

The Role of Non Steroidal Anti Inflammatory Drugs in the Treatment of Pleuropneumonia in Children. a Randomized Controlled Trial

Rabin Medical Center1 site in 1 country40 target enrollmentStarted: March 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Locations
1
Primary Endpoint
clinical improvement as manifested by resolution of fever and length of hospital admission.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to evaluate the influence of routine NSAIDs treatment for hospitalized children with pleuropneumonia in comparison with acetominophen treatment (all in conjunction with adequate antibiotic therapy).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •age less than 18 years
  • •admission in Schneider childrenMC of Israel, wards a/c
  • •clinical diagnosis of pneumonia with evidence of pleural effusion on chest X-ray
  • •parental informed consent
  • •follow-up ability after discharge

Exclusion Criteria

  • •pneumonia secondary to foreign body aspiration
  • •immune deficiency
  • •chronic lung disease other than asthma (CF, CLD of prematurity, Familial Dysautonomia, etc)
  • •significant premorbidity (organ failure, rheumatic disease, etc)
  • •endotracheal/endobronchial devices including tracheostomy.
  • •parental refusal to participate in the study.

Arms & Interventions

ibuprofen

Experimental

Intervention: Ibuprofen (Drug)

acetaminophen

Active Comparator

Intervention: Acetaminophen (Drug)

Outcomes

Primary Outcomes

clinical improvement as manifested by resolution of fever and length of hospital admission.

Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary Outcomes

  • clinical improvement as manifested by respiratory parameters (tachypnea, dyspnea, Fio2),and inflammatory markers.(participants will be followed for the duration of hospital stay, an expected average of 10 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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