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

NCT04877392 | Completed

• 1 other identifier: 2020/9373/I
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

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

• Change in heart rate

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

  Up to 5 minutes post-procedure

• Change in oxygen saturation

  Change in oxygen saturation (%)

  Up to 5 minutes post-procedure

Study Arms (2)

Control (usual measures to control pain)

NO INTERVENTION

The neonate was taken to the neonatal unit and monitored with a pulse-oximeter before, during and after the procedure. The neonate was swaddled, administered 1 mL of oral sucrose, and allowed to suck for 2 minutes prior to the procedure.

Case (usual measures to control pain plus inhaled lavender essential oil)

EXPERIMENTAL

The neonate was taken to the neonatal unit and monitored with a pulse-oximeter before, during and after the procedure. The neonate was swaddled, administered 1 mL of oral sucrose, and allowed to suck for 2 minutes prior to the procedure. The neonate also had a 7 x 7 cm gauze pad with 1 drop (43.75 mg) of 100% pure LEO (Pranarôm España S.L.) placed 2 cm under their nose for 2 minutes prior to starting the frenotomy and for the duration of the procedure.

Dietary Supplement: Lavender essential oil

Interventions

Lavender essential oil DIETARY_SUPPLEMENT

Use of inhaled lavender essential oil

Case (usual measures to control pain plus inhaled lavender essential oil)

Eligibility Criteria

• Age: 1 Day - 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 (August 2020 to April 2021)

You may not qualify if:

• Refusal of the patient's parents to participate

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (20)

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  PMID: 11600855 BACKGROUND

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  PMID: 8413140 BACKGROUND

• Lopez V, Nielsen B, Solas M, Ramirez MJ, Jager AK. Exploring Pharmacological Mechanisms of Lavender (Lavandula angustifolia) Essential Oil on Central Nervous System Targets. Front Pharmacol. 2017 May 19;8:280. doi: 10.3389/fphar.2017.00280. eCollection 2017.

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• Habanananda T. Non-pharmacological pain relief in labour. J Med Assoc Thai. 2004 Oct;87 Suppl 3:S194-202.

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  PMID: 12555281 BACKGROUND

• Sadathosseini AS, Negarandeh R, Movahedi Z. The effect of a familiar scent on the behavioral and physiological pain responses in neonates. Pain Manag Nurs. 2013 Dec;14(4):e196-e203. doi: 10.1016/j.pmn.2011.10.003. Epub 2012 Feb 28.

  PMID: 24315273 BACKGROUND

• Mikami-Saito Y, Maekawa M, Wada Y, Kanno T, Kurihara A, Sato Y, Yamamoto T, Arai-Ichinoi N, Kure S. Essential oils can cause false-positive results of medium-chain acyl-CoA dehydrogenase deficiency. Mol Genet Metab Rep. 2020 Nov 5;25:100674. doi: 10.1016/j.ymgmr.2020.100674. eCollection 2020 Dec.

  PMID: 33204637 BACKGROUND

• Goubet N, Strasbaugh K, Chesney J. Familiarity breeds content? Soothing effect of a familiar odor on full-term newborns. J Dev Behav Pediatr. 2007 Jun;28(3):189-94. doi: 10.1097/dbp.0b013e31802d0b8d.

  PMID: 17565285 RESULT

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  PMID: 20971562 RESULT

• Razaghi N, Aemmi SZ, Sadat Hoseini AS, Boskabadi H, Mohebbi T, Ramezani M. The effectiveness of familiar olfactory stimulation with lavender scent and glucose on the pain of blood sampling in term neonates: A randomized controlled clinical trial. Complement Ther Med. 2020 Mar;49:102289. doi: 10.1016/j.ctim.2019.102289. Epub 2019 Dec 26.

  PMID: 32147068 RESULT

• Akcan E, Polat S. Comparative Effect of the Smells of Amniotic Fluid, Breast Milk, and Lavender on Newborns' Pain During Heel Lance. Breastfeed Med. 2016 Aug;11(6):309-314. doi: 10.1089/bfm.2015.0174. Epub 2016 Jun 17.

  PMID: 27315487 RESULT

• Vaziri F, Khosropoor M, Hidari M, Pourahmad S, Morshed Behbahani B, Saki F. The Effect of Aromatherapy by Lavender Oil on Infant Vaccination Pain: a Double Blind Randomized Controlled Trial. J Caring Sci. 2019 Mar 1;8(1):17-21. doi: 10.15171/jcs.2019.003. eCollection 2019 Mar.

  PMID: 30915309 RESULT

• Cetinkaya B, Basbakkal Z. The effectiveness of aromatherapy massage using lavender oil as a treatment for infantile colic. Int J Nurs Pract. 2012 Apr;18(2):164-9. doi: 10.1111/j.1440-172X.2012.02015.x.

  PMID: 22435980 RESULT

• Field T, Field T, Cullen C, Largie S, Diego M, Schanberg S, Kuhn C. Lavender bath oil reduces stress and crying and enhances sleep in very young infants. Early Hum Dev. 2008 Jun;84(6):399-401. doi: 10.1016/j.earlhumdev.2007.10.008. Epub 2007 Nov 28.

  PMID: 18053656 RESULT

MeSH Terms

Conditions

Ankyloglossia; Pain

Interventions

lavender oil

Condition Hierarchy (Ancestors)

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

Study Officials

• Montserrat Fàbregas-Mitjans, Ph.D.

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

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: May 7, 2021
• Study Start: August 18, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: January 28, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)