Clinical trial NCT04724655: Paraffin Oil or Coconut Oil in Acute Aluminum Phosphide Poisoning
Official title: Gastric Lavage With Paraffin Oil or Coconut Oil in Management of Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Aluminum Phosphide Poisoning
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 89
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: death
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tantau
Study officials:
References: