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Use of troat pack in orthognathic surgery

Efficacy of Oropharyngeal pack in Orthognathic surgery - doble-blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9y4z7z
Enrollment
Unknown
Registered
2019-03-19
Start date
2018-11-13
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

Dentofacial functional abnormalities

Interventions

Fifty patients with facial deformity will be submitted to orthognathic surgery Patients will be allocated, after application of the inclusion / exclusion criteria, into the groups according to a rando
Procedure/surgery
Behavioural

Sponsors

Universidade de Pernambuco
Lead Sponsor
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 60 years; Climbing orthognathic surgery of the jaws; Physical state (ASA) I or II; That you have a chance to leave your study participation;

Exclusion criteria

Exclusion criteria: • Previous history of nausea and vomiting; • Previous history of motion sickness and migraine; • Difficulty in tracheal intubation; • When it was not possible to collect the data or to apply the proposed methodology; • Allergy to the drugs proposed in this study;

Design outcomes

Primary

MeasureTime frame
Primary outcome 1 - THROAT PAIN - Pain was assessed and recorded at 2h and 24h after tracheal extubation (T1 and T2 times, respectively), through visual analogue scale (VAS). Score 10 was attributed to more intense pain and 0 to absence of pain. To facilitate visualization of the results, the numerical variable was categorized as 0 without pain, 1-2 mild pain, 3-7 moderate pain, 8-10 severe pain.;Primary outcome 2 - DYSPHAGIA - Dysphagia was assessed by the presence or absence of difficulty in swallowing in the postoperative period. This variable was evaluated at 2h and 24h after surgery.;Primary outcome 3 - POSTOPERATIVE NAUSEA AND VOMITING (PONV). They were evaluated in the first 24 hours after surgery. In order to determine the intensity of PONV, we used the Kortilla's scale: without PONV; mild PONV index - few nausea or vomiting (less than 10 min in duration), having a temporal relationship with onset of diet or movement in the bed; Moderate PONV index - 2 episodes of intense / moderate nausea or vomiting, with no temporal relation to diet or movement, and who used antiemetic; severe NVPO Index - 3 or more episodes of vomiting and who took antiemetic.

Secondary

MeasureTime frame
No secondary outcomes were expected

Countries

Brazil

Contacts

Public ContactTatiane Faro

Universidade de Pernambuco

tatianefonsecafaro@gmail.com+5581996689345

Outcome results

None listed

Source: REBEC (via WHO ICTRP)