Paraffin Oil or Coconut Oil in Acute Aluminum Phosphide Poisoning

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT04724655
Collaborator
(none)
89
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3
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10.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: gastric lavage with paraffin oil and bicarbonate
  • Other: gastric lavage with coconut oil and bicarbonate
  • Drug: standard treatment
  • Other: gastric lavage with saline and bicarbonate
Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Gastric Lavage With Paraffin Oil or Coconut Oil in Management of Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial.
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Sep 15, 2021

Arms and Interventions

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

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

Drug: standard treatment
inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate

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

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

Drug: standard treatment
inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate

Outcome Measures

Primary Outcome Measures

  1. death [72 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tantau Tanta Egypt

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
samah maher, faculty of medicine,tanta university,Tanta Elgeesh street,qism 2,Egypt, Tanta University
ClinicalTrials.gov Identifier:
NCT04724655
Other Study ID Numbers:
  • oils and aluminum phosphide
First Posted:
Jan 26, 2021
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2022