Investigation of the effect of 2% nitroglycerin ointment - 2% lidocaine on the pain control due to intravenous catheter in infants; randomized double-blind clinical trial

Investigation of the effect of nitroglycerin-lidocaine ointment on the control of pain caused by intravenous catheter in infants

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 84 patients

After registering the proposal on the registry site http://irct.ir and obtaining permission from the ethics committee, 84 neonates under the age of one month that hospitalize in the NICU will enter the study. Patients in 2 groups will receive each topical lidocaine/nitroglycerin or placebo ointments by the permuted block method.

Newborns with cesarean section or non-complicated cesarean section and gestational age more than 34 weeks and postnatal age less than 4 weeks undergoing catheterization

The first group: lidocaine / nitroglycerin topical combination ointment, the second group: placebo topical ointment.

pain score of catheterization, How long does the baby cry after catheterization? How long it takes for the baby to start crying, Duration of the procedure.

In this study, 84 patients are randomly allocated into two treatment groups (A and B). Block randomization method will be used for random allocation. Fourteen blocks of six are considered. The generated permutations include the letters A and B, which are repeated thrice (for example, ABBABA) in each permutation. These permutations are generated using Random allocation software version 1. For this purpose, the generated list by the software is from 1 to 84, which are arranged in 14 blocks of six in order. To run this software output, we give the first qualified person number 1 and the last person will receive number 84. To consider blinding in random allocation, the list is given to another person outside the study and using short message service (SMS) before assigning the type of treatment according to the number of eligible people is asked and thus people enter the study. In addition, in the software output, both numbers 1 to 84 and the permutations of the letters A and B can be seen.

The steps will be covered from the perspective of the patient, the treating physicianو, and the assessors. The first presenter identifies the sequence of assignments of patients according to the order of entry of the patients into the study, and puts the ointments (combination of nitroglycerin-lidocaine or placebo) into one-size boxes for patient use, and identifies them with A or B codes. The student then delivers the drugs to each individual patient.