Nalbuphine and Flurbiprofen for Oculoplastic Surgery

Sun Yat-sen University

Status: Completed

Conditions: Surgery; Pain; Anesthesia

Treatments: Drug: Nalbuphine and Flurbiprofen Axetil; Drug: Flurbiprofen Axetil; Drug: Nalbuphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03422887

201802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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330 participants in 3 patient groups

flurbiprofen axetil

Active Comparator group

Description:

flurbiprofen axetil intraoperative administration 100mg

Treatment:

Drug: Flurbiprofen Axetil

nalbuphine

Experimental group

Description:

nalbuphine intraoperative administration 0.1mg/kg

Treatment:

Drug: Nalbuphine

nalbuphine and flurbiprofen axetil

Experimental group

Description:

flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg

Treatment:

Drug: Nalbuphine and Flurbiprofen Axetil