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Paraffin Oil or Coconut Oil in Acute Aluminum Phosphide Poisoning

T

Tanta University

Status and phase

Completed
Early Phase 1

Conditions

Aluminum Phosphide Poisoning

Treatments

Other: gastric lavage with paraffin oil and bicarbonate
Other: gastric lavage with saline and bicarbonate
Drug: standard treatment
Other: gastric lavage with coconut oil and bicarbonate

Study type

Interventional

Funder types

Other

Identifiers

NCT04724655
oils and aluminum phosphide

Details and patient eligibility

About

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.

Full 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.

Enrollment

89 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

89 participants in 3 patient groups

control group
Other group
Description:
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
Treatment:
Other: gastric lavage with saline and bicarbonate
Drug: standard treatment
paraffin group
Active Comparator group
Description:
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
Treatment:
Other: gastric lavage with paraffin oil and bicarbonate
Drug: standard treatment
coconut group
Active Comparator group
Description:
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
Treatment:
Other: gastric lavage with coconut oil and bicarbonate
Drug: standard treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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