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NCT03562611 Clinical Trial

Postoperative Pain and Discomfort After Orbital Decompression

Pain Clinical Trial

Official title:
Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Orbital Decompression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03562611
Other study ID # 201806
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 8, 2018
Est. completion date September 30, 2018

Study information
Verified date December 2018
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after orbital decompression under general anesthesia.

Description:

To investigate postoperative analgesia achieved with intraoperative administration of intravenous nalbuphine and flurbiprofen axetil in patients undergoing orbital decompression

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date September 30, 2018
Est. primary completion date September 8, 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years to 75 Years
Eligibility Inclusion Criteria:

- 16-75 years old

- diagnosed as thyroid eye disease

- bone removal orbital decompression under general anesthesia

- American Society of Anesthesiologists (ASA) physical status of I-II

Exclusion Criteria:

- body mass index (BMI) <18.5 or >35

- any uncontrolled clinical problems

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nalbuphine
Nalbuphine administration during surgery
• Flurbiprofen Axetil
Flurbiprofen axetil administration during surgery
• Nalbuphine and Flurbiprofen Axetil
Nalbuphine and Flurbiprofen Axetil administration during surgery

Locations
Country Name City State
China Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain after orbital decompression Pain levels measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable ; this scale has been confirmed to be sensitive and reliable.Clinically significant postoperative pain was considered serious pain (NRS score =5). 24 hour after recovery
Secondary Discomfort after orbital decompression Discomfort levels were measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no discomfort and 10 represents the worst discomfort; this scale has been confirmed to be sensitive and reliable. Discomfort was defined as "sensation other than pain" and included nausea, vomiting, headache, and dizziness. Clinically significant postoperative discomfort was considered serious discomfort (NRS score =5) any time postoperatively. 24 hour after recovery
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