Clinical trial NCT02049619: Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting
Official title: Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting. A Prospective Randomized Double Blind Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nausea
Vomiting
Keywords: Pharyngeal pack
Nausea
Vomiting
orthognathic surgery
maxillary osteotomy
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pharyngeal packs can reduce nausea and vomiting in patients undergoing orthognathic surgery.

Detailed description: Post-operative nausea and vomiting (PONV) is one of the most frequent and distressing complications of anesthesia. Patients often rate that PONV is worse than postoperative pain. PONV alone is one of the leading causes for delayed discharge and unpleasant experiments. Although PONV is not always life-threatening, persistent cases can result in dehydration, esophageal rupture, aspiration and potential death. The massive ingested blood and the additional issue of an altered diet (full liquids) due to a short period of jaw immobilization may be associated with a higher prevalence of PONV after orthognathic surgeries.

Although most of antiemetic drugs can help prevent PONV, they cannot preclude vomiting resulting from irritating gastrointestinal stimuli such as blood in the stomach. Pharyngeal packs are thought to prevent the ingestion and aspiration of blood, cartilage and bone fragments during oral and maxillofacial surgeries. Whether pharyngeal packs can reduce the incidence of PONV is controversial. It is reported that pharyngeal packs are recommended for the purpose of preventing PONV in nasal surgeries. However, some authors suggest that pharyngeal packs have no impact on PONV or the prevalence of PONV is doubled during routine nasal surgeries. However, the population size in these studies is relatively small and the trials have significant methodological weakness. None of these trials totally addressed the issue of the pharyngeal packs on the PONV following nasal surgeries. Moreover, these studies include different types of nasal surgeries, not all of which can be assumed to have equivalent bleeding potential.

Orthognathic surgeries performed maxillary and mandibular osteotomies and are assumed to involve massive blood loss. Orofacial swelling and swallowing blood is common in the early postoperative period after orthognathic surgeries. Whether pharyngeal packs can reduce the swallowing blood and PONV is unknown. Thus, The objective of this study is to determine whether pharyngeal packs can reduce nausea and vomiting in patients undergoing orthognathic surgery.

Eligibility criteria: Inclusion Criteria:

* undergoing elective orthognathic surgery
* age 18-50 year olds
* signed informed consent

Exclusion Criteria:

* pregnant women
* past history of oesophageal surgery, oesophageal varices or stricture,
* patients who have received antiemetic medication in the 24 hours before surgery
* emergency surgery
* prior history of motion sickness and/or PONV, vertigo or migraine headaches

Primary outcomes:
measure: the incidence and severity of any nausea, emetic episodes (retching or vomiting), or both (i.e., postoperative nausea and vomiting) during the first 24 postoperative hours.
timeFrame: the first 24 postoperative hours
Secondary outcomes:
measure: The incidence and severity of throat pain
timeFrame: the first 24 postoperative hours
measure: the incidence of oral mucosal injury
timeFrame: the first 24 postoperative hours
measure: satisfactory scores of patients
timeFrame: the first 24 postoperative hours
Other outcomes:
Locations:
city: Shenyang
country: China
facility: School & Hospital of Stomatology, China Medical University
state: Liaoning
Study officials:
affiliation: School & Hospital of Stomatology, China Medical University, China
name: xia zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: