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Comparison of tracheal tubes for tracheal intubation in children undergoing surgery for tonsils removal

Comparison of tracheal tube cuffs filled with Air or Alkalinized Lidocaine in patients undergoing Tonsillectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9x4s6y
Enrollment
Unknown
Registered
2016-11-18
Start date
2014-01-10
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

Adenoids, chronic diseases of tonsils and adenoids

Interventions

Control group: 40 pediatric patients undergoing tonsillectomy under general anesthesia with tracheal intubation and tracheal tube cuffs filled with air plus intravenous administration of 0.1 ml/kg of
Drug
Device
E02.041
D06.472.040
D02.065.199.092.500
D01.210.450.150.875

Sponsors

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

Eligibility

Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children undergoing tonsillectomy or adenoidectomy under general anesthesia; aged between 4 and 12 years; both genders; physical status ASA I or II according to American Society of Anesthesiologists

Exclusion criteria

Exclusion criteria: Oropharyngeal and neck malformations and distortions; patients who had already been intubated or tracheostomized for the surgery; the previous presence of stridor or dysphonia; prolonged tracheal intubation required after surgery; laryngeal or oropharyngeal illness or surgery; requirement for the introduction of a nasogastric or orogastric tube; more than two attempts of tracheal intubation; infection at the surgical site verified during pre-anesthetic evaluation; need of intensive care unit after surgery (severe sleep apnea)

Design outcomes

Primary

MeasureTime frame
Reduction of the occurrence of sore throat in postoperative period evaluated by face pain scale for children, ranging from 0 (no pain) to 10 (maximum pain) and recorded as percentage of occurrence, according to a minimum difference of 12% in relation to control group—

Secondary

MeasureTime frame
Heart rate variation between before and after tracheal extubation, evaluated as percentage of variation, according to a minimum variation of 20% in relation to control group. Mean arterial pressure variation between before and after tracheal extubation, evaluated as percentage of variation, according to a minimum variation of 20% in relation to control group—

Countries

Brazil

Contacts

Public ContactLais Navarro e Lima

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP

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

Outcome results

None listed

Source: REBEC (via WHO ICTRP)