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Fentanyl Background Infusion for Acute Postoperative Pain

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01785823
Collaborator
(none)
99
Enrollment
1
Location
3
Arms
10.1
Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: FX2-2-2
  • Other: D6-4-2
  • Other: D8-4-2
 N/A

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 13 hr and 2.0 ml/hr during 324 hr, postoperatively.

Study Design

Study Type:
Interventional
Actual Enrollment :
99 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Efficacy of the Time-scheduled Decremental Continuous Infusion of Fentanyl for Postoperative Patient-controlled Analgesia After Total Intravenous Anesthesia
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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 fixed-rate of 2 ml/hr until the postoperative 24 hr

Other: 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), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 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, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.
Other Names:
  • decremantl PCA 6-4-2

    • Other: 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 (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 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, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.
    Other Names:
  • decremental PCA 8-4-2

    		•
    Active Comparator: 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 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,

    Other: 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 fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 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, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.
    Other Names:
  • decremental PCA

    • Other: 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 (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 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, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.
    Other Names:
  • decremental PCA 8-4-2

    		•
    Active Comparator: 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 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,

    Other: 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 fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 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, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.
    Other Names:
  • decremental PCA

    • Other: 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), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 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, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.
    Other Names:
  • decremantl PCA 6-4-2

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients who had undergone patient-controlled analgesia (PCA) after hysterectomy
    Exclusion Criteria:

    • neurologic disorders

    • psychiatric disorders

    • renal or hepatic disorders

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ajou University School of Medicine Suwon Gyeongki-do Korea, Republic of 443-721

    Sponsors and Collaborators

    • Ajou University School of Medicine

    Investigators

    • Principal Investigator: Jong Yeop Kim, M.D, Ajou University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jong Yeop Kim, Associate professor, Ajou University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT01785823
    Other Study ID Numbers:
    • AJIRB-DEV-DE1-11-288
    First Posted:
    Feb 7, 2013
    Last Update Posted:
    Feb 7, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Jong Yeop Kim, Associate professor, Ajou University School of Medicine
    analgesia
    fentanyl
    total intravenous anesthesia
    Additional relevant MeSH terms:
    Agnosia

    Study Results

    No Results Posted as of Feb 7, 2013