Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04440462
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2020-06-18
Brief Title:
Analgesia in Lingual Frenulotomy in the Newborn
Sponsor:
IRCCS Burlo Garofolo
Organization:
IRCCS Burlo Garofolo
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RE-GLU
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 childs 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None