comparing the efficacy of intrapleural injection of alteplase with intrapleural infusion of normal saline through a chest tube in patients with parapneumonic effusion requiring drainage referred to Akbar Hospital

Comparison of the effectiveness of intrapleural alteplase injection with intrapleural normal saline injection via chest tube in patients with parapneumonic effusion requiring drainage

A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 30 patients. The rand function of Excel software was used for randomization. The control group will receive normal saline, and the intervention group will receive plasminogen activator at a dose of 0.1 mg/kg body weight, administered into the pleural space three times every 8 hours for 3 days.

This study will be conducted at Akbar Children's Hospital in Mashhad. All patients with empyema will be visited by a pediatric specialist and randomly assigned to the intervention and control groups. Allocation concealment will be performed using sealed envelopes. The present study is double-blind, in which patients and the patient outcome assessor are unaware of the patient grouping.

Inclusion criteria: Pneumonia; effusion; (septa/loculation on US/paracentesis). Effusion: LDH>1000 or sugar<40 or Gram stain; or pus. Exclusion criteria: Bleeding/disorder or pneumothorax or persistent leak; or fistula.

The control group will receive normal saline, and the intervention group will receive plasminogen activator at a dose of 0.1 mg per kilogram of body weight, injected into the pleural space three times every eight hours for three days.

1- Days elapsed until fever resolution and respiratory distress improvement 2- Duration of need for intravenous antibiotics 3- Need for thoracotomy or VATS 4- Laboratory criteria of inflammation ESR-CRP-CBCdiff

Using random allocation software, a list of random blocks with variable sizes of 4 and 6 is designed, each block containing an equal number of groups, and a number is assigned to each block. The order of the contents of each group ensures a balanced allocation of individuals in the study groups. When each patient visits, one of the blocks is randomly selected and the patient is assigned to one of the groups according to the order of its contents.

1. Blinding of participants - Both types of drugs (intrapleural alteplase and intrapleural normal saline) are provided in identical containers (same brand, color, shape, and packaging). - Labels are marked only with random codes (e.g., A or B) and do not indicate the type of drug. - If the drugs have a different taste/smell, a neutral flavoring/color is used so that they are not distinguishable. 2. Blinding of investigators (drug prescribing team) - The research team does not have access to the randomization list (this list is managed by a pharmacist or a central system outside the team). - The drugs are pre-coded, and the investigator only gives the code (e.g., vial “A”) to the patient without knowing the contents. - In case of complications, reports are recorded without mentioning the treatment group. 3. Blinding of outcome assessors (data analysis team) - Samples are sent to the laboratory with numerical codes (not A/B). - The evaluators do not know which treatment group each sample belongs to.