NCT04867824 (LVEO-SME1) is a NA clinical trial of Case (use of inhaled vanilla essential oil) in Ankyloglossia, sponsored by Parc de Salut Mar.

Who is sponsoring NCT04867824?

NCT04867824 is sponsored by Parc de Salut Mar.

What drugs are being tested in NCT04867824?

Interventions in NCT04867824: Case (use of inhaled vanilla essential oil), Control (use of inhaled lavender essential oil).

What condition does NCT04867824 study?

NCT04867824 studies Ankyloglossia.

Is NCT04867824 still recruiting?

NCT04867824 is currently status unknown. Last updated 30 April 2021.

Last reviewed 2021-04-30 · How we verify

NCT04867824: LVEO-SME1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Use of Lavender vs Vanilla Essential Oil as Complementary Analgesia for Frenotomy in Healthy Newborns

Status unknown NA Last updated 30 April 2021

What this trial tests

NA trial testing Case (use of inhaled vanilla essential oil) in Ankyloglossia in 142 participants. Status unknown.

Timeline

10 May 2021

Primary endpoint
9 December 2021

31 December 2021

Quick facts

Lead sponsor	Parc de Salut Mar
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	142
Start date	10 May 2021
Primary completion	9 December 2021
Estimated completion	31 December 2021

Drugs / interventions tested

Case (use of inhaled vanilla essential oil)
Control (use of inhaled lavender essential oil)

Conditions studied

Ankyloglossia — all drugs for Ankyloglossia →

Sponsor

Parc de Salut Mar — full company profile →

Who can join

Adults 0 Days to 15 Days, any sex, with Ankyloglossia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Clipping of the tongue-tie is a common procedure that physicians perform in our neonatal unit to help establish breastfeeding. It is a painful technique where the measures usually performed to control pain (such as sucking) cannot be done at the time of the clipping because the technique is performed on the tongue. A previous study conducted at our center proved the benefits of inhaled lavender essential oil to control pain during frenotomy, for which inhaled essential oil is now routinely used when clipping a tongue-tie. The aim of this study was to compare the analgesic/soothing effect of inhaled lavender essential oil vs inhaled vanilla essential oil during the clipping of the tongue-tie. Participants will be newborns born at our hospital during the study period (expected to be May to December 2021). Patients will be offered to participate and will be enrolled in the study if their parents agree to and sign an informed consent. The use of inhaled lavender and vanilla essential oils is safe. No side effects have been found with their use. The procedure of the frenotomy will not change for patients who are enrolled in the study. At the moment, inhaled lavender essential oil is used as complementary analgesia for the clipping of tongue-ties in our neonatal unit. By demonstrating which of the two oils has better results, the investigators aim to improve pain management of the patients who undergo a frenotomy. This study will take place at the neonatal unit of Hospital del Mar, Barcelona, Spain.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Comparison of the analgesic effect of inhaled lavender vs vanilla essential oil for neonatal frenotomy: a randomized clinical trial (NCT04867824).
Maya-Enero S, Fàbregas-Mitjans M, Llufriu-Marquès RM, Candel-Pau J, et al · · 2022 · cited 6× · PMID 36076107 · DOI 10.1007/s00431-022-04608-3
Comparison of the analgesic effect of inhaled lavender vs vanilla essential oil for neonatal frenotomy: a randomized clinical trial (NCT04867824)
Maya-Enero S, Fàbregas-Mitjans M, Llufriu-Marquès MR, Candel-Pau J, et al · · 2022 · DOI 10.21203/rs.3.rs-1529919/v1

Verify or expand the search:

Other recruiting trials for Ankyloglossia

Currently open trials in the same condition.

NCT07512765 — Ankyloglossia and Its Effects on Breastfeeding, Feeding and Speech Disorders. A Prospective Study From Birth to 4 Years · active not recruiting

Other Parc de Salut Mar trials

Trials by the same sponsor.

NCT06163235 — Efficacy of a Mobile Application and Semi-attendance Program in Bariatric Surgery · NA · not yet recruiting
NCT07223450 — A Study on Oral and Intranasal Forms of Oxycodone in Healthy Volunteers Using Pharmacokinetic Modeling · Phase 1 · completed
NCT07504913 — Spanish Validation of KOQUSS-40 Questionnaire: Assessing QoL of Gastric Cancer Patients After Gastrectomy: SPQUSS-41 · recruiting
NCT06806072 — BALNEOTHERAPY FOR BREAST CANCER PATIENTS UNDERGOING ENDOCRINE THERAPY · NA · not yet recruiting
NCT04084795 — Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04867824 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Parc de Salut Mar
Last refreshed: 30 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04867824.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing