Paraffin Oil or Coconut Oil in Acute Aluminum Phosphide Poisoning

Early Phase 1

Completed

• Conditions: Aluminum Phosphide Poisoning
• Interventions: Other: gastric lavage with coconut oil and bicarbonate; Other: gastric lavage with paraffin oil and bicarbonate; Drug: standard treatment; Other: gastric lavage with saline and bicarbonate

• Registration Number: NCT04724655
• Lead Sponsor: Tanta University

Brief 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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-26
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-15
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Exclusion Criteria

• • Patients less than 12 years of age

  • Pregnant and lactating women.
  • Patients with ingestion or exposure to other substances in addition to aluminum phosphide.
  • Patients with other major medical conditions (e.g. cardiovascular disease, diabetes mellitus, renal or hepatic failure).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paraffin group	standard treatment	gastric lavage with paraffin oil and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate
control group	gastric lavage with saline and bicarbonate	gastric lavage with saline and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate
coconut group	gastric lavage with coconut oil and bicarbonate	gastric lavage with coconut oil and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate
control group	standard treatment	gastric lavage with saline and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate
paraffin group	gastric lavage with paraffin oil and bicarbonate	gastric lavage with paraffin oil and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate
coconut group	standard treatment	gastric lavage with coconut oil and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate

Primary Outcome Measures

Name	Time	Method
death	72 hours

Trial Locations

Locations (1)

Tantau; 🇪🇬 Tanta, Egypt