Comparison of single or three stage administration of oral sucrose drop 24% on reducing the pain of newborns admitted in the intensive care unit

Comparison of single or multiple phase administration of oral sucrose 24% for pain control in neonatal intensive care unit

The study is a randomized clinical trial. 120 newborns enter randomly in the first or second groups (60 subjects). Randomization is through random numbers table.

The study is conducted at Bu-Ali Sina hospital in Sari. The film is taken from the 30 seconds before the drug use until 60 seconds after it is consumed (except for the duration of the drug administration). The nurse is aware of the drug usage method. These videos are carefully evaluated by a neonatal specialist who is not aware of the intervention. Also, the results analyzer is not aware of the intervention done in each group.

Inclusion criteria: neonates in intensive care unit who need heel lance. The exclusion criteria: carbohydrate intolerance due to short gut syndrome ,metabolic or endocrine dysfunction (such as fructose or sucrose intolerance, diabetes), inability to tolerate oral administration of the solution to the tongue, absent/deficient protective airway reflexes, central nervous system dysfunction, use of sedation/analgesics, neuromuscular blocking agents, or anesthetic agents, patient with suspected or confirmed necrotizing enterocolitis, oral surgery, patients on a ketogenic diet, no feeding per oral and neonates with maternal anomaly in their faces

In this study, neonates receive oral sucrose 24% solution based on their weight, 0.3 mL/kg, either as a single dose 120 seconds (intervention group 1) or in three divided doses 120, 90 and 60 seconds (intervention group 2) before heel lance.

Pain score based on Premature Infant Pain Profile Revised (PIPP-R) criteria

Simple randomization. Patients based on random numbers table will enter to first or second groups.

The nurse is aware of drug administration method and at the time of drug taking, the film is not taken. The film is taken from the 30 seconds before the drug is started up to 60 seconds after it is consumed (except for the duration of the druguse) to assess the pain. These videos are carefully evaluated by a neonatologist who is not aware of the intervention done in each group. Statistical analyzer is also not aware of the intervention done in each group.

The data of the main outcome is published.

Since publishing up to 3 months

Only employees in academic centers

If a researcher needs to do a more careful study on the data.

It can be requested from the scientific responsible person.

After written request, it is examined and appropriate data is provided.