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Analgesic Effect of Inhaled Lavender Essential Oil for Clipping of Tongue-ties

NCT04877392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2022-01-28

No results posted yet for this study

Summary

Clipping of the tongue-tie is a common procedure that neonatologists perform in our neonatal unit to help establish breastfeeding. It is a painful technique where the measures healthcare providers usually perform to control pain (such as sucking) cannot be done at the time of the clipping because the technique is performed on the tongue. The aim of this study was to prove that inhaled lavender essential oil during the clipping of the tongue-tie can help control pain. Participants were newborns born at our hospital during the study period. They were offered to participate and enrolled in the study if their parents agreed to and signed an informed consent. The use of inhaled lavender essential oil is safe. No side effects have been found with its use. The procedure of the frenotomy did not change for patients who were enrolled in the study. By demonstrating that inhaled lavender essential oil helps reduce pain, its use was included as part of the regular measures to control pain during frenotomies at our neonatal unit (Hospital del Mar, Barcelona, Spain). The study started in August 2020 and ended in April 2021.

Conditions

  • Ankyloglossia

Interventions

DIETARY_SUPPLEMENT

Lavender essential oil

Use of inhaled lavender essential oil

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Montserrat Fàbregas-Mitjans, Ph.D. · Hospital del Mar

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
15 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2021-04-15
Completion
2021-04-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04877392 on ClinicalTrials.gov