Corn oil for gastric decontamination in acute aluminum phosphide poisoning: A randomized controlled trial

To evaluate efficacy and safety of corn oil for gastric decontamination as a part of the management of patients with acute aluminum phosphide poisoning.

Two arm parallel group, single blind, randomized controlled trial of 98 patients, enrolled between June 2020 and June 2021.

Tanta Poison Control Center (Emergency Hospital, Tanta University), Tanta, Egypt. Participants will be blinded by making a letter for each medication used and masking the name of the medication.

We will include patients (male or female, aged 12 to 70 years-old) with aluminum phosphide ingestion who present to the hospital within two hours from ingestion. We will exclude patients who vomit within one hour after ingestion, dissolve the aluminum phosphide pill(s) in water prior to ingestion, ingest or are exposed to substances other than aluminum phosphide, present more than 2 hours of having consumed aluminum phosphide, are treated for aluminum phosphide poisoning in other medical facilities before admission, and pregnant and lactating women.

All patients will receive standard patient resuscitation, adequate hydration, and supportive treatment. Gastric decontamination will be carried out through aspiration of gastric contents via a nasogastric tube using 60 ml syringe, with no patient positioning or fluid instillation. In group I (control group), gastric lavage will be performed using sodium bicarbonate. In group II (intervention group), 60 ml corn oil will be administered following aspiration of gastric contents.

o All-cause mortality during hospital admission o Proportion of patients requiring intubation o Duration of ventilation o Duration of hospital stay

We used the sealed, opaque sequentially numbered envelopes method for randomization and allocation concealment of patients included in this trial as described by Doig and Simpson (2005). We used 98 identical, opaque, letter-sized envelopes. We used 2 rolls of household aluminum cooking foil that we cut into 98 sheets (of the same width as and twice the height of the envelope). We prepared 98 envelope-sized sheets of white paper and 98 envelope-sized sheets of single sided carbon paper. We wrote “Treatment A” on 49 paper sheets and “Treatment B” on the other 49 sheets. To prepare 49 Treatment A envelops, we selected one envelope-sized sheet of of Treatment A and placed one sheet of carbon paper on top of the Treatment A allocation paper with the carbon side facing the paper, then we put both papers inside a foil wrapper. Then, the completed insert was placed into a blank envelope with the carbon paper closest to the front of the envelope. Finally, the envelop was sealed and we signed across the seal. We completed all the 49 Treatment A envelops the same way. We prepared 49 Treatment B envelops the same way as Treatment A envelops. Both sets of envelops were combined and we shuffled them thoroughly. Then, using a pen we marked a number on the front of each envelope sequentially from 1 to 98. The carbon paper inside the envelope will transfer this number to the allocation paper inside. Finally, we placed these envelopes into a plastic container, in numerical order, ready for use. Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care 2005;20:187–93.

Only participants will be masked. We will achieve this by making a letter for each medication used and masking the name of the medication.

We plan to share all IPD that underlie results

Data will become available 6 months and ending 36 months following article publication

Researchers from academic institutions whose proposal for the use of data has been approved by an independent review committee identified for this purpose

For IPD meta-analysis

Data will be obtainable from the PI

A proposal for the use of data to be submitted to the PI, then evaluated by an independent review committee identified for this purpose