Caudal Bupivacaine vs Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Children

March 10, 2015 updated by: Khaled Radian Al-zaben, University of Jordan

Comparison of Caudal Bupivacaine Alone With Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Infra-umbilical Surgery: A Randomized Controlled Double Blinded Study

The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of two doses of dexmedetomidine (1 and 2 µg.kg-1) co-administered with bupivacaine with bupivacaine alone for caudal analgesia in children undergoing infra-umbilical surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Quality assurance plan for data validation and registry: After Data was registered, it was reviewed by a second person who compared it to the Data in patient data collection forms.
  • Data check: carried out using Statistical Package for the Social Sciences (SPSS) variable definition protocols. Also data were entered in EXCEL sheets for comparisons to guarantee consistency.
  • Source data verification: Paper case report forms and medical records.
  • Standard Operating Procedures to address registry operations and analysis activities: Eligible patients were recruited after obtaining consent. Data was collected by qualified personnel rained on the process. Data was entered into Excel sheets and SPSS programs and compared for consistency. Analysis of Data was carried out by a qualified statistician. Adverse events were reported as yes/no variables. Data of patients who had Change in management was omitted from analysis.
  • Sample size assessment: Sample size was calculated to detect a 65% reduction in the analgesic requirement during the first 24 h from 75% in the bupivacaine group with α= 0.05 and β=0.80.
  • Plan for missing data: Patients with missing Data were omitted from statistical analysis.
  • Statistical analysis plan: carried out using International Business Machines (IBM) statistics 19.0 statistical package for windows. Data were compared using analysis of variance for continuous variables, Kruskal-Wallis test for ordinal, and chi square test for categorical ones. Post hoc analyses were carried out as appropriate.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients with American Society of Anesthesiologists (ASA) - I
  • Scheduled for lower abdominal and perineal surgery
  • Under general anesthesia

Exclusion criteria:

  • history of developmental delay or mental retardation
  • known or suspected coagulopathy or recent use of anticoagulant/antiplatelet drugs.
  • known allergy to any of the study drugs.
  • any signs of infection or congenital abnormalities at the site of the proposed caudal block

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine
single shot caudal plain bupivacaine at a dose of 2mg/kg is used as a reference control drug.
Drug: Bupivacaine
Caudal Bupivacaine 2 mg/kg single shot
Other Names:
  • Broup B
Active Comparator: dexmedetomidine 1μg.kg-1
Single shot Caudal dexmedetomidine 1μg.kg-1 used as the second arm intervention
Drug: dexmedetomidine 1μg.kg-1
Caudal dexmedetomidine 1μg.kg-1, single shot
Other Names:
  • Group BD1
Active Comparator: dexmedetomidine 2μg.kg-1
Single shot Caudal dexmedetomidine 2 μg.kg-1 used as the second arm intervention
Drug: dexmedetomidine 2μg.kg-1
Caudal dexmedetomidine 2μg.kg-1, single shot
Other Names:
  • Group BD2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first analgesic requirement
Time Frame: 24 hours
The time from end of surgery to the first requirement of postoperative analgesia
24 hours
Postoperative pain scores
Time Frame: 24 hours
24 hours
Number of postoperative analgesia doses
Time Frame: 24 hours
Number of paracetamol doses needed by each patient
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative sedation scores
Time Frame: 2 hours
Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals.
2 hours
Sevoflurane concentration
Time Frame: intraoperative
Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60%.
intraoperative
Blood pressure
Time Frame: intraoperative
Intraoperative blood pressure readings
intraoperative
Heart Rate
Time Frame: intraoperative
Intraoperative heart rate readings
intraoperative
Side effects of study drugs
Time Frame: 24 hours
Any side effects of study drugs in the first 24 hours postoperative hours were recorded (nausea, Vomiting, urine retention, lower limb weakness and emesis).
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Investigators

  • Principal Investigator: khaled R Al-zaben, University of Jordan
  • Study Director: Ibraheem Y Qudaisat, University of Jordan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of jordan

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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