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.

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.

Study Overview

• Status: Completed
• Conditions: Aluminum Phosphide Poisoning
• Intervention / Treatment: Drug: standard treatment; Other: gastric lavage with saline and bicarbonate; Other: gastric lavage with paraffin oil and bicarbonate; Other: gastric lavage with coconut oil and bicarbonate

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 Type: Interventional
• Enrollment (Actual): 89
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • TantaU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group; 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	Drug: standard treatment; inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate; Other: gastric lavage with saline and bicarbonate; Gastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube
Active Comparator: paraffin group; 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	Drug: standard treatment; inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate; Other: gastric lavage with paraffin oil and bicarbonate; 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
Active Comparator: coconut group; 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	Drug: standard treatment; inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate; Other: gastric lavage with coconut oil and bicarbonate; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
death	72 hours

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning; Dermatologic Agents; Emollients; Mineral Oil
• Other Study ID Numbers: oils and aluminum phosphide

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No