Clinical Trials Directory

Trials / Completed

CompletedNCT04724655

Paraffin Oil or Coconut Oil in Acute Aluminum Phosphide Poisoning

Gastric Lavage With Paraffin Oil or Coconut Oil in Management of Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial.

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
89 (actual)
Sponsor
Tanta University · Academic / Other
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

The aim of the present study is to evaluate safety and efficacy of gastric lavage with paraffin oil or gastric lavage with coconut oil in management of acute Aluminum phosphide poisoning.

Detailed description

60 patients will be randomly assigned as control groups, paraffin group, and coconut group in a 1:1:1 ratio (30 patients in each group). Inclusion criteria: * Patients with symptomatic acute aluminum phosphide poisoning * Age is more than 12 years of both gender * Patients presenting within 6 hours post-ingestion of aluminum phosphide (Papade and Vanjari, 2019). The diagnosis is made on the basis of: 1. The suggestive clinical manifestations due to and following shortly after a single exposure to aluminum phosphide. 2. Reliable identification of the compound based on the container brought by patient attendants. 3. Biochemical detection of phosphine gas in gastric aspirate (silver nitrate test). * Group (I): Gastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube (Control group) * Group (II): Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution 8.4%, then aspiration will be done after 3-5 min through nasogastric tube (Paraffin group). * Group (III): Gastric lavage will be initiated with 50 ml coconut oil and 50 ml sodium bicarbonate 8.4 % then aspiration will be done after 3-5 min through nasogastric tube (Coconut group). * All patients will continue to receive the standard supportive treatment according to Tanta University Poison Control Center protocol, which is determined by the attending physician who maintains clinical responsibility for all patients. Conventional standard treatment included using inotropes, fluids and electrolytes resuscitation, intubation, mechanical ventilation and antiarrhythmic agents if indicated.

Conditions

Interventions

TypeNameDescription
OTHERgastric lavage with paraffin oil and bicarbonateGastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution 8.4%, then aspiration will be done after 3-5 min through nasogastric tube
OTHERgastric lavage with coconut oil and bicarbonateGastric lavage will be initiated with 50 ml coconut oil and 50 ml sodium bicarbonate 8.4 % then aspiration will be done after 3-5 min through nasogastric tube
DRUGstandard treatmentinotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate
OTHERgastric lavage with saline and bicarbonateGastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube

Timeline

Start date
2021-01-01
Primary completion
2021-06-30
Completion
2021-09-15
First posted
2021-01-26
Last updated
2022-06-08

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04724655. Inclusion in this directory is not an endorsement.