Analgesia in Lingual Frenulotomy in the Newborn

NCT ID: NCT04440462

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-18
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sugar and water solution

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

Group Type: EXPERIMENTAL

Sugar and water solution

Intervention Type: OTHER

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

Sterile water

2 ml of sterile water

Group Type: ACTIVE_COMPARATOR

Sterile water

Intervention Type: OTHER

2 ml of sterile water

Interventions

Sugar and water solution

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

Intervention Type: OTHER

Sterile water

2 ml of sterile water

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 10 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maddalena Chermetz, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

Institute for maternal and child health Burlo Garofolo

Milena Cadenaro, DDS MSc PhD

Role: STUDY_DIRECTOR

Institute for maternal and child health Burlo Garofolo

Chiara Navarra, DDS MSc PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for maternal and child health Burlo Garofolo

Locations

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, Trieste, Italy

Countries

Italy

Other Identifiers

RC 13/2019

Identifier Type: -

Identifier Source: org_study_id