Fentanyl Background Infusion for Acute Postoperative Pain

Not Applicable

Completed

• Conditions: Analgesia Disorder
• Interventions: Other: D6-4-2; Other: FX2-2-2; Other: D8-4-2

• Registration Number: NCT01785823
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-10
• Status Verified: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-06
• Last Update Submitted: 2013-02-06
• Study First Posted: 2013-02-07
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

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

Exclusion Criteria

• neurologic disorders
• psychiatric disorders
• renal or hepatic disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FX2-2-2	D6-4-2	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
FX2-2-2	D8-4-2	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
D6-4-2	FX2-2-2	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,
D6-4-2	D8-4-2	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,
D8-4-2	FX2-2-2	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,
D8-4-2	D6-4-2	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,

Primary Outcome Measures

Name	Time	Method
visual analogue scores (VAS)	until post-operative 24 hrs	The assessments of analgesia and patient condition were performed at the time points of immediate post-operative periods (1, 15, 30, 45, and 60 min) and post-operative 2, 3, 4, 6, 12 and 24 hr.

Trial Locations

Locations (1)

Ajou University School of Medicine; 🇰🇷 Suwon, Gyeongki-do, Korea, Republic of