Analgesia in Lingual Frenulotomy in the Newborn

NCT04440462 | Completed

• 1 other identifier: RC 13/2019
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frenulum Breve

Keywords

Ankyloglossia; Frenulotomy; water and sugar solution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain reduction

  During the frenulotomy

• Cortical oxy-haemoglobin change

  30 seconds after the frenulotomy

Study Arms (2)

Sugar and water solution

EXPERIMENTAL

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

Sterile water

ACTIVE COMPARATOR

2 ml of sterile water

Other: Sterile water

Interventions

Sugar and water solution OTHER

2 ml of a water and sugar solution (3 full-teaspoons of granulated sugar dissolved in half glass of water)

Sugar and water solution

Sterile water OTHER

2 ml of sterile water

Sterile water

Eligibility Criteria

• Age: 1 Day - 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, Trieste, 34137, Italy

Location

MeSH Terms

Conditions

Ankyloglossia

Interventions

Sugars

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Maddalena Chermetz, DDS MSc

  Institute for maternal and child health Burlo Garofolo

  PRINCIPAL INVESTIGATOR

• Milena Cadenaro, DDS MSc PhD

  Institute for maternal and child health Burlo Garofolo

  STUDY DIRECTOR

• Chiara Navarra, DDS MSc PhD

  Institute for maternal and child health Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 19, 2020
• Study Start: September 18, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)