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

NCT04867824 | Unknown

• 1 other identifier: 2021/9731/I
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

ankyloglossia; tongue-tie; aromatherapy; lavender; vanilla; pain; neonate; frenotomy

Outcome Measures

Primary Outcomes (4)

• Crying length

  Crying length after the frenotomy in seconds

  Up to 5 minutes post-procedure

• NIPS score

  Neonatal Infant Pain Score value (0-7). NIPS evaluates facial expression, crying, breathing pattern, arm and leg position, and state of arousal on a scale from 0 to 7, where 0-2 means no pain to mild pain, 3-4 mild to moderate pain, and \>4 severe pain.

  Up to 5 minutes post-procedure

• Increase in heart rate

  Increase in heart rate pre/post-procedure (beats per minute)

  Up to 5 minutes post-procedure

• Decrease in oxygen saturation

  Decrease in oxygen saturation (%)

  Up to 5 minutes post-procedure

Study Arms (2)

Control

ACTIVE COMPARATOR

The neonate will be taken to the neonatal unit and monitored with a pulse-oximeter before, during and after the procedure. We will swaddle it, will administer 1 mL of oral sucrose, let the newborn suck for 2 minutes prior to the procedure, and will have a 7 x 7 cm gauze pad with 1 drop of 100% pure LEO (Pranarôm España S.L.) placed 2 cm under the nose for 2 minutes prior to starting the frenotomy and during the procedure.

Dietary Supplement: Control (use of inhaled lavender essential oil)

Case

EXPERIMENTAL

The neonate will be taken to the neonatal unit and monitored with a pulse-oximeter before, during and after the procedure. We will swaddle it, will administer 1 mL of oral sucrose, let the newborn suck for 2 minutes prior to the procedure, and will have a 7 x 7 cm gauze pad with 1 drop of 100% pure vanilla essential oil (Pranarôm España S.L.) placed 2 cm under the nose for 2 minutes prior to starting the frenotomy and during the procedure.

Dietary Supplement: Case (use of inhaled vanilla essential oil)

Interventions

Case (use of inhaled vanilla essential oil) DIETARY_SUPPLEMENT

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

Case

Control (use of inhaled lavender essential oil) DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 0 Days - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy full-term neonates born at Hospital del Mar (Barcelona, Spain), or less than 15 days old who had been discharged and returned for the frenotomy, who underwent a frenotomy for type 3 tongue-ties according to Coryllos classification and the Hazelbaker tool during the study period

You may not qualify if:

• Refusal of the patient's parents to participate

Sponsors & Collaborators

• Parc de Salut Mar: lead

Related Publications (21)

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• Maya-Enero S, Fabregas-Mitjans M, Llufriu-Marques RM, Candel-Pau J, Garcia-Garcia J, Lopez-Vilchez MA. Comparison of the analgesic effect of inhaled lavender vs vanilla essential oil for neonatal frenotomy: a randomized clinical trial (NCT04867824). Eur J Pediatr. 2022 Nov;181(11):3923-3929. doi: 10.1007/s00431-022-04608-3. Epub 2022 Sep 8.

  PMID: 36076107 DERIVED

MeSH Terms

Conditions

Ankyloglossia; Pain

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvia Maya-Enero, Ph.D., M.D.

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Maya-Enero, Ph.D., M.D.

CONTACT

+34 93 248 3145; 62175@parcdesalutmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: May 10, 2021
• Primary Completion: December 9, 2021
• Study Completion: December 31, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share