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Completed

NCT Number: NCT04724655

Paraffin Oil or Coconut Oil in Acute Aluminum Phosphide Poisoning

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Tantau

Tanta, Egypt

About this study

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:

  • The suggestive clinical manifestations due to and following shortly after a single exposure to aluminum phosphide.
  • Reliable identification of the compound based on the container brought by patient attendants.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

gastric lavage with paraffin oil and bicarbonate

Other

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

gastric lavage with coconut oil and bicarbonate

Other

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

standard treatment

Drug

inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate

gastric lavage with saline and bicarbonate

Other

Gastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube

Primary outcomes

  1. death

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2021
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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