Analgesia in Lingual Frenulotomy in the Newborn

Frenulum Breve Clinical Trial

— RE-GLU  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04440462
• Other study ID #: RC 13/2019
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: IRCCS Burlo Garofolo
• Contact: Milena Cadenaro, DDS MSc PhD
• Phone: +390403785675
• Email: milena.cadenaro[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 10 Days

Eligibility

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).

Related Conditions & MeSH terms

• Frenulum Breve

Intervention

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)
• Sterile water
2 ml of sterile water

Locations

Country	Name	City	State
Italy	Institute for Maternal and Child Health - IRCCS Burlo Garofolo-	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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