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

NCT04867824 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2021-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Ankyloglossia

Interventions

DIETARY_SUPPLEMENT

Case (use of inhaled vanilla essential oil)

Use of inhaled vanilla essential oil during frenotomy for a tongue-tie

DIETARY_SUPPLEMENT

Control (use of inhaled lavender essential oil)

Use of inhaled lavender essential oil during frenotomy for a tongue-tie

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Silvia Maya-Enero, Ph.D., M.D. · Hospital del Mar

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
15 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2021-12-09
Completion
2021-12-31

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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 NCT04867824 on ClinicalTrials.gov