Comparison of the analgesic effect of inhaled lavender vs vanilla essential oil for neonatal frenotomy: a randomized clinical trial (NCT04867824).
- 2022-09-08
- European journal of pediatrics 181(11)
- Silvia Maya-Enero
- Montserrat Fàbregas-Mitjans
- Rosa Maria Llufriu-Marquès
- Júlia Candel-Pau
- Jordi Garcia-Garcia
- María Ángeles López-Vílchez
- PubMed: 36076107
- DOI: 10.1007/s00431-022-04608-3
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 142
- Population
- 142 neonates with type 3 tongue-ties undergoing frenotomy
- Methods
- Randomized clinical trial; both groups received swaddling, oral sucrose, and 2 min sucking; gauze pad with one drop of essential oil (lavender or vanilla) placed under nose for 2 min prior to and during frenotomy; pain assessed by HR, SatO2, crying time, NIPS score.
- Funding
- Unclear
- Large Human Trial
It is necessary to treat neonatal pain because it may have short- and long-term adverse effects. Frenotomy is a painful procedure where sucking, a common strategy to relieve pain, cannot be used because the technique is performed on the tongue. In a previous randomized clinical trial, we demonstrated that inhaled lavender essential oil (LEO) reduced the signs of pain during neonatal frenotomy. We aimed to find out whether inhaled vanilla essential oil (VEO) is more effective in reducing pain during frenotomy than LEO. Randomized clinical trial with neonates who underwent a frenotomy for type 3 tongue-ties between May and October 2021. Pain was assessed using pre and post-procedure heart rate (HR) and oxygen saturation (SatO2), crying time, and NIPS score. Neonates were randomized into "experimental" and "control" group. In both groups, we performed swaddling, administered oral sucrose, and let the newborn suck for 2 min. We placed a gauze pad with one drop of LEO (control group) or of VEO (experimental group) under the neonate's nose for 2 min prior to and during the frenotomy. We enrolled 142 neonates (71 per group). Both groups showed similar NIPS scores (2.02 vs 2.38) and crying times (15.3 vs 18.7 s). We observed no differences in HR increase or in SatO2 decrease between both groups. We observed no side effects in either of the groups.
Conclusions
We observed no appreciable difference between LEO and VEO; therefore, we cannot conclude which of them was more effective in treating pain in neonates who underwent a frenotomy.Trial registration
This clinical trial is registered with www.Clinicaltrials
gov with NCT04867824.What is known
• Pain management is one of the most important goals of neonatal care as it can have long-term neurodevelopmental effects. • Lavender essential oil can help relieve pain due to its sedative, antispasmodic, and anticolic properties.What is new
• Lavender and vanilla essential oils are safe, beneficial, easy to use, and cheap in relieving pain in neonates who undergo a frenotomy for type 3 tongue-ties.Research Insights
Both groups showed similar ... crying times (15.3 vs 18.7 s).
- Effect
- Neutral
- Effect size
- Small
- Dose
- one drop (no further specification)
We observed no differences in HR increase or in SatO2 decrease between both groups.
- Effect
- Neutral
- Effect size
- Small
- Dose
- one drop (no further specification)
We observed no differences in HR increase or in SatO2 decrease between both groups.
- Effect
- Neutral
- Effect size
- Small
- Dose
- one drop (no further specification)
Both groups showed similar NIPS scores (2.02 vs 2.38) ... We observed no differences in HR increase or in SatO2 decrease between both groups.
- Effect
- Neutral
- Effect size
- Small
- Dose
- one drop (no further specification)
Adverse Events Reported
We observed no side effects in either of the groups.
- Finding
- Reported