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Completed

NCT Number: NCT04440462

Analgesia in Lingual Frenulotomy in the Newborn

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.

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Key information

Age range

1 day–10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, 34137, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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)

Sterile Water

Other

2 ml of sterile water

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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)

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Acronym: RE-GLU

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 19, 2020
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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