drugset / Trial / NCT06869902

Use of Inhaled Colostrum to Control Pain in Neonatal Frenotomy and Comparison to Inhaled Lavender Essential Oil

NCT06869902 ↗

Completed 142 enrolled Parc de Salut Mar
RandomizedParallel-groupTriple-blindSupportive care

Summary

Neonatal pain must be treated because it may have long-term negative effects. Frenotomy (clipping the tongue-tie) is a painful procedure where common strategies to relieve pain (give oral sucrose, let the baby suck, etc) cannot be used because the technique is performed on the tongue. Inhaling lavender essential oil (LEO) helps treat pain during painful procedures such as blood sampling, vaccination, and frenotomy. We aimed to determine whether smelling colostrum had similar effects as inhaled LEO during frenotomies. We conducted a prospective, randomized clinical trial between September 2023 and June 2024 and evaluated babies who underwent a frenotomy. We assessed pain using the NIPS score, heart rate, oxygen saturation, and crying time. After obtaining parental informed consent, we randomized patients into experimental and control groups. In both groups, we performed swaddling, administered oral sucrose, and let the newborn suck for 2 minutes. In the experimental group, we placed a gauze pad with two drops of colostrum, whereas in the control group, we used one drop of LEO 2 cm under the neonate's nose prior to and during the frenotomy.

Timeline

Start
2023-09-18
Primary completion
2024-06-14
Completion
2024-06-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Colostrum Protein / enzyme biologic 2 unknown Inhaled

Indications