Investigating the effect of indomethacin on the clinical outcome of patients with severe non-hemorrhagic traumatic brain injury, a randomized placebo-controlled study

Investigating the effect of indomethacin on the clinical outcome of patients with severe traumatic brain injury

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 30 patients. Random Allocation was used for randomization.

Eligible patients will be randomly selected and placed in one of two intervention groups (group A) and placebo (group B) by block randomization method. Random Allocation software version 2 will be used for random arrangement of samples in blocks. In this software, we set the number of groups to 2 (1: group A and 2: group B), and the number of samples to 30 (based on the sample size), the size of the blocks is equal, and the coding is a combination of letters and We put a random number. The statistically significant level will also be set at 0.05. SNOSE method is used for the purpose of concealment (blinding) of random allocation. The location of the Imam Khomeini Hospital project in Sari

Registration of informed consent from the patient's first-degree companion to participate in the study, age 16 to 70 years, severe traumatic brain injury with non-hemorrhagic closed or penetrating mechanism, high ICP resistant to treatment, GCS ≤ 8

Two intervention groups (group A) and placebo (group B), and we set the number of samples to 30 (based on the sample size), the size of the blocks is equal, and we set the coding as a combination of letters and numbers and random. The statistically significant level will be set at 0.05.

Sao2, Pao2, Paco2, mRS and body temperature parameters will be measured before administration. Sao2, Pao2 and Paco2 parameters will be measured 30, 60 and 120 minutes after receiving the drug. mRS and GOS will be re-measured one month and 6 months after administration

Eligible patients will be randomly selected and placed in one of two intervention groups (group A) and placebo (group B) by block randomization method. Random Allocation software version 2 will be used for random arrangement of samples in blocks. In this software, we set the number of groups to 2 (1: group A and 2: group B), and the number of samples to 30 (based on the sample size), the size of the blocks is equal, and the coding is a combination of letters and We put a random number. The statistically significant level will be set at 0.05.

In order to hide (blinding) the random allocation, the SNOSE method is used. This method is one of the common methods in hiding random allocation. In this method, first, a random sequence is created using the mentioned software, then based on the sample size, a number of envelopes with aluminum envelopes (in order to make the contents of the envelopes unclear) are prepared and each of the random sequences created ( intervention or control group) is recorded on a card and the cards are placed in the envelopes in order. In order to preserve the random sequence, naming is done on the outer surface of the envelopes in the same order as it was produced by the software (for example: TF8G is written on the envelope and the card inside the intervention envelope). Finally, the lids of the envelopes are glued and placed in a box. At the time of starting the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed.