Analgesia in Lingual Frenulotomy in the Newborn

Overview

Ankyloglossia (tongue-tie) is a congenital anomaly characterized by a short lingual frenulum that limits the physiological tongue movement and occurs with an estimated prevalence between 4 and 10% of the newborns. This condition can be associated with difficulty in breastfeeding which can be painful for the mother, dysfunctional swallowing and future speech difficulties. The prevalence of nipple pain among women breastfeeding newborns with ankyloglossia is estimated to be between 36 and 80%. Since an early intervention can prevent the difficulties that may occur during the child's growth and can also improve the mothers and patients' quality of life, it is important to evaluate the lingual frenulum in the first days of life. The treatment of ankyloglossia consists in the frenulotomy which allows the release of the lingual frenulum and is a relatively simple procedure with few side effects and minimal post-operative. Different methods performed with or without local anaesthesia by means of scissors, blade, laser (etc.) are described in literature for the procedure the newborn. The hypothesis of the study is that the addition of a water and sugar solution to the standard analgesia with lidocaine may lead to a greater benefit in terms of pain control and determine the activation of different brain areas. The primary aim of the study is to evaluate whether the administration of a water and sugar solution to newborns undergoing frenulotomy receiving topical lidocaine as standard analgesic protocol, may lead to an additional benefit in terms of pain reduction evaluated according to the Neonatal Infant Pain Scale (NIPS). The secondary aim of the study is to evaluate through a Hitachi multichannel near-infrared spectroscopy (NIRS) the effects of the addition of a water and sugar solution to the standard analgesic protocol with topical lidocaine on the cortical activation.

Full Title of Study: “Lingual Frenulotomy in the Newborn: a Randomized Clinical Trial to Evaluate the Analgesic Effect of a Water and Sugar Solution in a Minor Surgical Procedure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 1, 2022

Interventions

  • Other: Sugar and water solution
    • 2 ml of a water and sugar solution (3 full-teaspoons of granulated sugar dissolved in half glass of water)
  • Other: Sterile water
    • 2 ml of sterile water

Arms, Groups and Cohorts

  • Experimental: Sugar and water solution
    • 2 ml of a water and sugar solution (3 full-teaspoons of granulated sugar dissolved in half glass of water)
  • Active Comparator: Sterile water
    • 2 ml of sterile water

Clinical Trial Outcome Measures

Primary Measures

  • Pain reduction
    • Time Frame: 30 seconds after the frenulotomy
    • The perception of pain in newborns will be evaluated according to the Internationally Validated Neonatal Infant Pain Scale (NIPS).This scale detects the presence of six behavioral expression signs of neonatal pain (facial expression, crying, respiratory pattern, arms and legs’ activity, arousal state) and ranges from 0 (absence of pain) to 7 (maximal pain level).

Secondary Measures

  • Pain reduction
    • Time Frame: During the frenulotomy
    • The perception of pain in newborns will be evaluated according to the Internationally Validated Neonatal Infant Pain Scale (NIPS).This scale detects the presence of six behavioral expression signs of neonatal pain (facial expression, crying, respiratory pattern, arms and legs’ activity, arousal state) and ranges from 0 (absence of pain) to 7 (maximal pain level).
  • Cortical oxy-haemoglobin change
    • Time Frame: 30 seconds after the frenulotomy
    • Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2) (Hitachi multichannel NIRS system)

Participating in This Clinical Trial

Inclusion Criteria 1. Term newborns (37 – 41 weeks of gestational age) within the first 10 days of life; 2. Birth weight ≥ 2500 grams; 3. Presence of ankyloglossia; 4. Indication to the frenulotomy according to the Hazelbaker Assessment Tool for Lingual Frenulum Function (HATLFF): anatomical-functional evaluation with a score lower than 8. Exclusion Criteria:

1. Syndromic diagnosis (genetic/hereditary); 2. Pathology of main organ (heart disease, brain disease etc.); 3. Drugs intake that may interfere with the collected data (sedatives).

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 10 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • IRCCS Burlo Garofolo
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maddalena Chermetz, DDS MSc, Principal Investigator, Institute for maternal and child health Burlo Garofolo
    • Milena Cadenaro, DDS MSc PhD, Study Director, Institute for maternal and child health Burlo Garofolo
    • Chiara Navarra, DDS MSc PhD, Principal Investigator, Institute for maternal and child health Burlo Garofolo
  • Overall Contact(s)
    • Milena Cadenaro, DDS MSc PhD, +390403785675, milena.cadenaro@burlo.trieste.it

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