Evidence map›Paper›PMID 36076107›Full record

Trial reportEuropean journal of pediatrics2022

Comparison of the analgesic effect of inhaled lavender vs vanilla essential oil for neonatal frenotomy: a randomized clinical trial (NCT04867824).

Silvia Maya-Enero, Montserrat Fàbregas-Mitjans, Rosa Maria Llufriu-Marquès, Júlia Candel-Pau, Jordi Garcia-Garcia, María Ángeles López-Vílchez

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of pediatrics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04867824 naunknown statusnot on this map

Comparison of Lavender vs Vanilla Essential Oil as Complementary Analgesia for Frenotomy in Healthy Newborns: a Randomized Clinical Trial.

TypeinterventionalSponsorParc de Salut MarRan2021 to 2021Enrolled142ConditionsAnkyloglossiaArmsCase (use of inhaled vanilla essential oil), Control (use of inhaled lavender essential oil)
NCT06869902 nacompletednot on this mapstarted 2023, after this paper: background citation

Is Inhaled Colostrum as Effective as Inhaled Lavender Essential Oil for Pain Control in Neonatal Frenotomy: A Prospective, Randomized Clinical Trial

TypeinterventionalSponsorParc de Salut MarRan2023 to 2024Enrolled142ConditionsPain, Ankyloglossia, NeonateArmsColostrum
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Neonatal Pain Management: Is There An Endocrinal Response?Endocrine, metabolic & immune disorders drug targets · 2025
    Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Silvia Maya-EneroDepartment of Neonatology, Service of Pediatrics, Hospital del Mar, Parc de Salut Mar, Universitat Pompeu Fabra, Passeig Marítim 25-29, 08003, Barcelona, Spain. smaya@psmar.cat.
Montserrat Fàbregas-MitjansDepartment of Neonatology, Service of Pediatrics, Hospital del Mar, Parc de Salut Mar, Universitat Pompeu Fabra, Passeig Marítim 25-29, 08003, Barcelona, Spain.
Rosa Maria Llufriu-MarquèsDepartment of Neonatology, Service of Pediatrics, Hospital del Mar, Parc de Salut Mar, Universitat Pompeu Fabra, Passeig Marítim 25-29, 08003, Barcelona, Spain.
Júlia Candel-PauDepartment of Neonatology, Service of Pediatrics, Hospital del Mar, Parc de Salut Mar, Universitat Pompeu Fabra, Passeig Marítim 25-29, 08003, Barcelona, Spain.
Jordi Garcia-GarciaDepartment of Neonatology, Service of Pediatrics, Hospital del Mar, Parc de Salut Mar, Universitat Pompeu Fabra, Passeig Marítim 25-29, 08003, Barcelona, Spain.
María Ángeles López-VílchezDepartment of Neonatology, Service of Pediatrics, Hospital del Mar, Parc de Salut Mar, Universitat Pompeu Fabra, Passeig Marítim 25-29, 08003, Barcelona, Spain.
Parc de Salut · ESPompeu Fabra University · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

conclusionsWe 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 registrationThis 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.

Indexed as

AnkyloglossiaLavandulaOils, VolatileVanillaAnalgesicsBreast FeedingFemaleHumansHypnotics and SedativesInfant, NewbornLingual FrenumPainParasympatholyticsSucroseAnalgesicsHypnotics and SedativesOils, VolatileParasympatholyticsSucroseAnkyloglossiaAromatherapyFrenotomyLavenderNeonatal painNeonateTongue-tieVanilla

Identifiers

PMID36076107
PMCPMC9458311
OpenAlexW4295077507

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.