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Comparison of tracheal tubes for children's tracheas intubation

Comparison of the use of uncuffed tracheal tube versus cuffed tracheal tubes filled with saline solution, lidocaine or air in pediatric patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3y357v
Enrollment
Unknown
Registered
2016-09-19
Start date
2012-01-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hernia inguinal, hidrocele

Interventions

Experimental groups: (1) 41 patients undergoing surgery under general anesthesia with tracheal intubation and tracheal tubes filled with 0.5% alkalinized lidocaine solution. (2) 41 patients undergoing
Device

Sponsors

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP
Lead Sponsor
Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP
Collaborator

Eligibility

Age
3 Years to 13 Years

Inclusion criteria

Inclusion criteria: Children undergoing general anesthesia; aged between 3 and 13 years; both genders; physical status 1 or 2 according to American Society of Anesthesiologists; minor or medium level surgery

Exclusion criteria

Exclusion criteria: Oropharyngeal and neck malformations and distortions; patients who had already been intubated or tracheostomised; previous presence of stridor or dysphonia; laryngeal or oropharyngeal illness or surgery; requirement for the introduction of a nasogastric or orogastric tube; more than two attempts at tracheal intubation; use of corticosteroids during the perioperative period; the use of local anaesthetic agents administered through a route other than that used to fill the tracheal tube cuffs

Design outcomes

Primary

MeasureTime frame
Reduction of the occurrence of sore throat in postoperative period evaluated by face pain scale, ranging from 0 (no pain) to 10 (maximum pain) and recorded as percentage of occurrence;Outcome evaluated: Sore throat at the post anesthesia care unit (values are % of occurrence): Group Air (control): 12.2%; Group Normal saline: 12.2%; Group 0.5% Alkalinized lidocaine: 2.4%; Group 1% Alkalinized lidocaine: 2.4% (qui-square test, p = 0.12). Sore throat 8 hours after tracheal extubation (values are % of occurrence): Group Air (control): 22.0%; Group Normal saline: 9.8%; Group 0.5% Alkalinized lidocaine: 4.8%; Group 1% Alkalinized lidocaine: 2.4% (qui-square test, p = 0.015). Then, pairwise comparison performed: Group Air vs. Group 0.5% Alkalinized lidocaine, p 0.05.

Secondary

MeasureTime frame
Measurement of plasma levels of lidocaine, by blood sample collected 30 minutes after tracheal intubation;Outcome evaluated: Plasma lidocaine concentration. Values are mean and standard deviation, between parentheses, and are expressed as ng/dl: Group 0.5% Alkalinized lidocaine: 48.4 (53.7) Group 1% Alkalinized lidocaine: 77.4 (217.61) p = 0.56

Countries

Brazil

Contacts

Public ContactPaulo do Nascimento Junior

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP

pnasc@fmb.unesp.br+55(14)38801414

Outcome results

None listed

Source: REBEC (via WHO ICTRP)