Fentanyl Background Infusion for Acute Postoperative Pain

Ajou University School of Medicine

Status: Completed

Conditions: Analgesia Disorder

Treatments: Other: D6-4-2; Other: D8-4-2; Other: FX2-2-2

Study type: Interventional

Funder types: Other

Identifiers

NCT01785823

AJIRB-DEV-DE1-11-288

Details and patient eligibility

About

We investigated the efficacy and the safety of the pharmacokinetic model-based patient-controlled analgesia (PCA) regimens of fentanyl for postoperative analgesia after total intravenous anesthesia (TIVA).

Full description

Infusions of fentanyl (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr, or at the decremental rates of 6.0 ml/hr or 8.0 ml/hr during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively.

Enrollment: 99 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who had undergone patient-controlled analgesia (PCA) after hysterectomy

Exclusion criteria

• neurologic disorders
• psychiatric disorders
• renal or hepatic disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 3 patient groups

FX2-2-2

Experimental group

Description:

Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr

Treatment:

Other: D8-4-2

Other: D6-4-2

D6-4-2

Active Comparator group

Description:

Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the decremental rates of 6.0 ml/hr (D6-4-2) during 1 hr, 4.0 ml/hr during 1\~3 hr and 2.0 ml/hr during 3\~24 hr,

Treatment:

Other: D8-4-2

Other: FX2-2-2

D8-4-2

Active Comparator group

Description:

Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at at the decremental rates of 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1\~3 hr and 2.0 ml/hr during 3\~24 hr,

Treatment:

Other: FX2-2-2

Other: D6-4-2