Postoperative Pain and Discomfort After Orbital Decompression
Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Orbital Decompression
1 other identifier
interventional
63
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable surgery
Started Jun 2018
Shorter than P25 for not_applicable surgery
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2018
CompletedStudy Start
First participant enrolled
June 8, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedDecember 26, 2018
December 1, 2018
3 months
June 7, 2018
December 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Discomfort after orbital decompression
24 hour after recovery
Study Arms (3)
flurbiprofen axetil
ACTIVE COMPARATORflurbiprofen axetil intraoperative administration 100mg
nalbuphine
EXPERIMENTALnalbuphine intraoperative administration 0.1mg/kg
nalbuphine and flurbiprofen axetil
EXPERIMENTALflurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg
Interventions
Nalbuphine and Flurbiprofen Axetil administration during surgery
Eligibility Criteria
You may qualify if:
- years old
- diagnosed as thyroid eye disease
- bone removal orbital decompression under general anesthesia
- American Society of Anesthesiologists (ASA) physical status of I-II
You may not qualify if:
- body mass index (BMI) \<18.5 or \>35
- any uncontrolled clinical problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huijing Ye
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 7, 2018
First Posted
June 19, 2018
Study Start
June 8, 2018
Primary Completion
September 8, 2018
Study Completion
September 30, 2018
Last Updated
December 26, 2018
Record last verified: 2018-12