Analgesia in Lingual Frenulotomy in the Newborn (RE-GLU)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Frenulum Breve
• Intervention / Treatment: Other: Sugar and water solution; Other: Sterile water

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Milena Cadenaro, DDS MSc PhD; Phone Number: +390403785675; Email: milena.cadenaro@burlo.trieste.it
• Study Contact Backup: Name: Chiara Navarra, DDS MSc PhD; Phone Number: +390403785675; Email: chiara.navarra@burlo.trieste.it

Study Locations

• Italy
  • Trieste, Italy, 34137
    • Recruiting
    • Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
    • Contact: Milena Cadenaro; Email: milena.cadenaro@burlo.trieste.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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)
Active Comparator: Sterile water; 2 ml of sterile water	Other: Sterile water; 2 ml of sterile water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain reduction	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).	30 seconds after the frenulotomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain reduction	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).	During the frenulotomy
Cortical oxy-haemoglobin change	Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2) (Hitachi multichannel NIRS system)	30 seconds after the frenulotomy

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Principal Investigator: Maddalena Chermetz, DDS MSc, Institute for maternal and child health Burlo Garofolo; Study Director: Milena Cadenaro, DDS MSc PhD, Institute for maternal and child health Burlo Garofolo; Principal Investigator: Chiara Navarra, DDS MSc PhD, Institute for maternal and child health Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2020
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Ankyloglossia; Frenulotomy; water and sugar solution
• Other Study ID Numbers: RC 13/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No