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NCT03422887 Clinical Trial

Nalbuphine and Flurbiprofen for Oculoplastic Surgery

Pain Clinical Trial

Official title:
Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Oculoplastic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03422887
Other study ID # 201802
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2018
Est. completion date September 30, 2018

Study information
Verified date January 2021
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 oculoplastic surgery under general anesthesia.

Description:

In this randomized controlled clinical trial, we evaluated the postoperative analgesic efficacy and adverse effects of flurbiprofen axetil combined with nalbuphine in patients undergoing oculoplastic surgery compared with a single dose of flurbiprofen axetil or nalbuphine.

Recruitment information / eligibility
Status Completed
Enrollment 330
Est. completion date September 30, 2018
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years to 75 Years
Eligibility Inclusion Criteria: - Undergoing oculoplastic surgery - age between 16 and 75 years - American Society of Anesthesiologists (ASA) physical status of I-II Exclusion Criteria: - serious coexisting disease - body mass index (BMI) <18.5 or >35 - contraindications or previous adverse reactions to any of the drugs used - females with a positive pregnancy test - patients unable to cooperate

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 24 hours after recovery 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 hours after recovery
Secondary Discomfort 24 hours after recovery 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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