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

IRCCS Burlo Garofolo

Status: Enrolling

Conditions: Frenulum Breve

Treatments: Other: Sugar and water solution; Other: Sterile water

Study type: Interventional

Funder types: Other

Identifiers

NCT04440462

RC 13/2019

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 1 to 10 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Sugar and water solution

Experimental group

Description:

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

Treatment:

Other: Sugar and water solution

Sterile water

Active Comparator group

Description:

2 ml of sterile water

Treatment:

Other: Sterile water