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The Use of Lavender vs Vanilla Essential Oil as Complementary Analgesia for Frenotomy in Healthy Newborns (LVEO-SME1)

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ClinicalTrials.gov Identifier: NCT04867824
Recruitment Status : Not yet recruiting
First Posted : April 30, 2021
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ankyloglossia Dietary Supplement: Case (use of inhaled vanilla essential oil) Dietary Supplement: Control (use of inhaled lavender essential oil) Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Comparison of Lavender vs Vanilla Essential Oil as Complementary Analgesia for Frenotomy in Healthy Newborns: a Randomized Clinical Trial.
Estimated Study Start Date : May 10, 2021
Estimated Primary Completion Date : December 9, 2021
Estimated Study Completion Date : December 31, 2021

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control
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)
Use of inhaled lavender essential oil during frenotomy for a tongue-tie
Experimental: Case
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)
Use of inhaled vanilla essential oil during frenotomy for a tongue-tie


Outcome Measures
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Primary Outcome Measures :
  1. Crying length [ Time Frame: Up to 5 minutes post-procedure ]
    Crying length after the frenotomy in seconds

  2. NIPS score [ Time Frame: Up to 5 minutes post-procedure ]
    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.

  3. Increase in heart rate [ Time Frame: Up to 5 minutes post-procedure ]
    Increase in heart rate pre/post-procedure (beats per minute)

  4. Decrease in oxygen saturation [ Time Frame: Up to 5 minutes post-procedure ]
    Decrease in oxygen saturation (%)


Eligibility Criteria
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Ages Eligible for Study:   up to 15 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Refusal of the patient's parents to participate
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04867824


Contacts
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Contact: Silvia Maya-Enero, Ph.D., M.D. +34 93 248 3145 62175@parcdesalutmar.cat

Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Principal Investigator: Silvia Maya-Enero, Ph.D., M.D. Hospital del Mar
More Information
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Publications:

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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT04867824    
Other Study ID Numbers: 2021/9731/I
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parc de Salut Mar:
ankyloglossia
tongue-tie
aromatherapy
lavender
 vanilla
pain
neonate
frenotomy
Additional relevant MeSH terms:
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Ankyloglossia
Stomatognathic Diseases