Analgesic Effect of Inhaled Lavender Essential Oil for Clipping of Tongue-ties
Condition: Ankyloglossia
MeSH terms: Ankyloglossia
Study type: Interventional

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.
    

Detailed description: 
      This randomized clinical trial was conducted with the neonates born at our hospital or less
      than 15 days old 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).
      Healthcare providers assessed pain by means of crying time and the highest Neonatal Infant
      Pain Scale (NIPS) score in the five minutes post procedure, and whether there was an increase
      in heart rate (HR) and decrease in oxygen saturation (satO2). 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. In an exploratory preliminary study prior to the intervention, a mean (SD) crying time
      of 19.80 (21.14) seconds was observed. In order to detect a difference of 10 seconds in
      crying time, a sample size of 71 patients per group was required in order to draw conclusions
      with a CI 95% and a power of 80%. Patients were enrolled if their parents agreed to and
      signed a written informed consent.

      Data were recorded on demographic (gender, gestational age, birth weight, age in hours at the
      time of frenotomy) and clinical variables (HR and satO2 before, during, and after the
      procedure, whether there was crying or not during the procedure, length of crying time in
      seconds, presence of side effects during the procedure (apnea, desaturation, others) and
      highest NIPS score within the first 5 minutes after the procedure). The independent variable
      was the use or not of aromatherapy during frenotomy. The dependent variables were: HR and
      satO2 pre and post procedure, presence of crying and duration, hours of life at the time of
      the frenotomy, and the NIPS score. The controlled variables were gestational age, sex, and
      birth weight.

      All the newborns are assessed for the presence of ankyloglossia as part of the routine
      neonatal evaluation and a frenotomy is offered to all tongue-tied patients. The examiner
      grades the ankyloglossia based on Coryllos's criteria and the Hazelbaker tool to assess its
      impact on tongue movement and on breastfeeding. A lingual frenulum is symptomatic if it
      scores 8 points or less in appearance and/or 11 points or less in function according to
      Hazelbaker. Advice and help with positioning and attachment for breastfeeding is provided to
      all the mothers by IBCLC (International Board Certified Lactation Consultant) nurses. During
      the study period, if a patient with a type 3 tongue-tie was identified, the patient's parents
      were offered to participate in this study. Accepted patients were allocated into case or
      control group by simple random sampling using the program OxMAR (Online Minimization and
      Randomization for Clinical Trials). During the frenotomy the neonate was taken to the
      neonatal unit and monitored with a pulse-oximeter (COVIDIEN Nellcor Portable SpO2 Patient
      Monitoring System PM10N, Covidien Ireland Limited, IDA Business & Technology Park, Tullamore,
      Ireland) before, during and after the procedure. For both groups, neonates were swaddled,
      administered 1 mL of oral sucrose, and allowed to suck for 2 minutes prior to the procedure.
      The experimental group 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. The bottle of LEO has a dropper that always
      dispenses the same amount of oil per drop. The procedure did not start the procedure until
      the patients were calm and had a NIPS score of 0. Frenotomy was performed by one of the three
      staff neonatologists using Coryllos' technique: placing a sterile groove director under the
      tongue straddling the frenulum, holding the frenulum in place with visualization of tongue
      base and frenulum, and snipping the frenulum with a scissor along the underside of the tongue
      to its base just proximal to the genioglossus muscle, until a full release is achieved. Once
      the procedure was completed, the gauze pad was removed and vital signs, whether the baby
      cried or not, the seconds crying lasted, and the post procedure NIPS score were registered on
      a data collection sheet. If a neonate cried, calming techniques such as holding, swaddling,
      and sucking were employed. Following the frenotomy, the neonate was returned to the mother
      for breastfeeding.

      Statistical analysis: Quantitative variables (gestational age, birth weight, age at
      frenotomy, heart rate pre and post-procedure, increase in heart rate post-procedure, oxygen
      saturation pre and post-procedure, decrease in oxygen saturation post-procedure, and duration
      of crying) are described using the mean, standard deviation, and 95% confidence interval
      (CI); case vs control groups were compared with a Student's t test. Gender, the presence of
      crying, and adverse effects between the two groups are presented in percentages and compared
      using Fisher's exact test. NIPS scores between cases and controls were compared with the
      Wilcoxon rank-sum (Mann-Whitney) test. Statistical significance was set for a p <0.05.
      Statistical analyses were performed using STATA version 15.1 (StataCorp, College Station, TX,
      USA).

      Our hospital Ethics Committee (CEIm-PSMAR) approved this study (reference code: 2020/9373/I).
      Prior to patient enrollment, a signed informed consent was obtained from the neonate's
      parents. This study was conducted according to the ethics code of the Barcelona Medical
      Association and the principles of the Helsinki-Fortaleza Declaration 2013.
    

Intervention name(s): Lavender essential oil
Intervention type(s): Dietary Supplement
Intervention description(s): Use of inhaled lavender essential oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: ankyloglossia; tongue-tie; aromatherapy; lavender; pain; neonate