NSAIDs Treatment in Children With Pleuropneumonia

Pleuro-pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01586299
• Other study ID #: 262-11-RMC
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2012
• Last updated: November 13, 2014
• Start date: March 2012
• Est. completion date: June 2015

Study information

• Verified date: January 2012
• Source: Rabin Medical Center
• Contact: shai ashkenazi, Prof
• Phone: 972-3-9253680
• Email: sashkenazi[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pleuro-pneumonia
• Pleuropneumonia
• Pneumonia

Intervention

Drug:
• Ibuprofen
10 mg/kg every 8 hours until 24 hours after resolution of fever
• Acetaminophen
15 mg/kg every 6 hours until 24 hours after resolution of fever

Locations

Country	Name	City	State
Israel	Schneider's medical center of Israel	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical improvement as manifested by resolution of fever and length of hospital admission.		participants will be followed for the duration of hospital stay, an expected average of 10 days	No
Secondary	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	No