The Effect of Intravenous Lidocaine on Pain After Tonsillectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Chung-Ang University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Chung-Ang University Hospital
ClinicalTrials.gov Identifier:
NCT01291979
First received: February 8, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted

February 8, 2011
February 8, 2011
February 2011
January 2012   (final data collection date for primary outcome measure)
Visual analogue scale 4hour [ Time Frame: post op 4hour ] [ Designated as safety issue: No ]

Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

To check the severity of pain VAS will be measured at post op 4hour.

Same as current
No Changes Posted
  • visual analogue scale 12 hour [ Time Frame: Post op 12 hour ] [ Designated as safety issue: No ]

    Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

    To check the severity of pain VAS will be measured at post op 12 hour.

  • visual analogue scale 24hour [ Time Frame: Post op 12 hour ] [ Designated as safety issue: No ]

    Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

    To check the severity of pain VAS will be measured at post op 12 hour.

  • Visual analogue scale 48hour [ Time Frame: Post Op 48hour ] [ Designated as safety issue: No ]

    Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

    To check the severity of pain VAS will be measured at post op 48 hour.

  • Opioid consumption 4hour [ Time Frame: Post Op 4hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 4hour will be measured.
  • Opioid consumption 24hour [ Time Frame: Post op 24 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from 12 hour to post op 24 hour will be measured.
  • Opioid consumption 12 hour [ Time Frame: Post Op 12 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from post op 4hour to post op 12 hour will be measured.
  • Opioid consumption 48hour [ Time Frame: Post Op 48 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from post op 24 hour to post op 48 hour will be measured
  • FPB 4 hour [ Time Frame: Post Op 4 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 4 hour will be measured.
  • FPB 12 hour [ Time Frame: post op 12 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) from post op 4 hour to post op 12 hour will be measured.
  • FPB 24 hour [ Time Frame: Post Op 24 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 12 hour to post op 24 hour will be measured.
  • FPB 48 hour [ Time Frame: Post Op 48 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 24 hour to post op 48 hour will be measured.
Same as current
Not Provided
Not Provided
 
The Effect of Intravenous Lidocaine on Pain After Tonsillectomy
Intravenous Lidocaine for Effective Pain Relief After Tonsillectomy: a Prospective, Randomized, Double-blind, Placebo-controlled Study

This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing tonsillectomy.

A total of 62 patients will be randomized into one of two groups (group C or group I) based on Excel number generation.

Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain
  • Drug: Intravenous lidocaine injection
    Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
    Other Name: IV lidocaine
  • Drug: Intravenous normal saline injection
    The patients in Group C (placebo control group) received normal saline intravenous injection
    Other Name: IV saline
  • Active Comparator: Intravenous lidocaine injection group
    Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
    Intervention: Drug: Intravenous lidocaine injection
  • Placebo Comparator: Placebo control group
    Patients in Group C (placebo control group) received normal saline intravenous injection
    Intervention: Drug: Intravenous normal saline injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
62
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Tonsillectomy

Exclusion Criteria:

  • mental change
  • allergy to local anesthetics
Both
18 Years to 65 Years
No
Contact: Hyun Kang, Ph.D. 82-2-6299-2571 roman00@naver.com
Korea, Republic of
 
NCT01291979
ChungAngUH1
No
Kyung Soo Kim, Chung-Ang University Hospital
Chung-Ang University Hospital
Not Provided
Study Chair: Hyun Kang, Ph.D. Chungang University Hospital
Principal Investigator: KyungSoo Kim, Ph.D. Chungang University Hospital
Chung-Ang University Hospital
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP