Clinical trial NCT04440462: Analgesia in Lingual Frenulotomy in the Newborn
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frenulum Breve
Keywords: Ankyloglossia
Frenulotomy
water and sugar solution
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Pain reduction
timeFrame: 30 seconds after the frenulotomy
Secondary outcomes:
measure: Pain reduction
timeFrame: During the frenulotomy
measure: Cortical oxy-haemoglobin change
timeFrame: 30 seconds after the frenulotomy
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Study officials:
affiliation: Institute for maternal and child health Burlo Garofolo
name: Maddalena Chermetz, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for maternal and child health Burlo Garofolo
name: Milena Cadenaro, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Institute for maternal and child health Burlo Garofolo
name: Chiara Navarra, DDS MSc PhD
role: PRINCIPAL_INVESTIGATOR
References: