Caudal Bupivacaine vs Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Children
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bupivacaine
dexmedetomidine 1μg.kg-1
dexmedetomidine 2μg.kg-1
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring caudal block
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Bupivacaine
dexmedetomidine 1μg.kg-1
dexmedetomidine 2μg.kg-1
Arm Description
single shot caudal plain bupivacaine at a dose of 2mg/kg is used as a reference control drug.
Single shot Caudal dexmedetomidine 1μg.kg-1 used as the second arm intervention
Single shot Caudal dexmedetomidine 2 μg.kg-1 used as the second arm intervention
Outcomes
Primary Outcome Measures
Time to first analgesic requirement
The time from end of surgery to the first requirement of postoperative analgesia
Postoperative pain scores
Number of postoperative analgesia doses
Number of paracetamol doses needed by each patient
Secondary Outcome Measures
Postoperative sedation scores
Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals.
Sevoflurane concentration
Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60%.
Blood pressure
Intraoperative blood pressure readings
Heart Rate
Intraoperative heart rate readings
Side effects of study drugs
Any side effects of study drugs in the first 24 hours postoperative hours were recorded (nausea, Vomiting, urine retention, lower limb weakness and emesis).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02385435
Brief Title
Caudal Bupivacaine vs Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Children
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
caudal block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
single shot caudal plain bupivacaine at a dose of 2mg/kg is used as a reference control drug.
Arm Title
dexmedetomidine 1μg.kg-1
Arm Type
Active Comparator
Arm Description
Single shot Caudal dexmedetomidine 1μg.kg-1 used as the second arm intervention
Arm Title
dexmedetomidine 2μg.kg-1
Arm Type
Active Comparator
Arm Description
Single shot Caudal dexmedetomidine 2 μg.kg-1 used as the second arm intervention
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Broup B
Intervention Description
Caudal Bupivacaine 2 mg/kg single shot
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine 1μg.kg-1
Other Intervention Name(s)
Group BD1
Intervention Description
Caudal dexmedetomidine 1μg.kg-1, single shot
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine 2μg.kg-1
Other Intervention Name(s)
Group BD2
Intervention Description
Caudal dexmedetomidine 2μg.kg-1, single shot
Primary Outcome Measure Information:
Title
Time to first analgesic requirement
Description
The time from end of surgery to the first requirement of postoperative analgesia
Time Frame
24 hours
Title
Postoperative pain scores
Time Frame
24 hours
Title
Number of postoperative analgesia doses
Description
Number of paracetamol doses needed by each patient
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative sedation scores
Description
Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals.
Time Frame
2 hours
Title
Sevoflurane concentration
Description
Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60%.
Time Frame
intraoperative
Title
Blood pressure
Description
Intraoperative blood pressure readings
Time Frame
intraoperative
Title
Heart Rate
Description
Intraoperative heart rate readings
Time Frame
intraoperative
Title
Side effects of study drugs
Description
Any side effects of study drugs in the first 24 hours postoperative hours were recorded (nausea, Vomiting, urine retention, lower limb weakness and emesis).
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khaled R Al-zaben
Organizational Affiliation
University of Jordan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ibraheem Y Qudaisat
Organizational Affiliation
University of Jordan
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
25203847
Citation
Tong Y, Ren H, Ding X, Jin S, Chen Z, Li Q. Analgesic effect and adverse events of dexmedetomidine as additive for pediatric caudal anesthesia: a meta-analysis. Paediatr Anaesth. 2014 Dec;24(12):1224-30. doi: 10.1111/pan.12519. Epub 2014 Sep 9.
Results Reference
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PubMed Identifier
24383602
Citation
She YJ, Zhang ZY, Song XR. Caudal dexmedetomidine decreases the required concentration of levobupivacaine for caudal block in pediatric patients: a randomized trial. Paediatr Anaesth. 2013 Dec;23(12):1205-12. doi: 10.1111/pan.12278. Epub 2013 Oct 12.
Results Reference
background
PubMed Identifier
25040840
Citation
Bharti N, Praveen R, Bala I. A dose-response study of caudal dexmedetomidine with ropivacaine in pediatric day care patients undergoing lower abdominal and perineal surgeries: a randomized controlled trial. Paediatr Anaesth. 2014 Nov;24(11):1158-63. doi: 10.1111/pan.12478. Epub 2014 Jul 12.
Results Reference
background
PubMed Identifier
19076110
Citation
Saadawy I, Boker A, Elshahawy MA, Almazrooa A, Melibary S, Abdellatif AA, Afifi W. Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatrics. Acta Anaesthesiol Scand. 2009 Feb;53(2):251-6. doi: 10.1111/j.1399-6576.2008.01818.x. Epub 2008 Dec 6.
Results Reference
background
PubMed Identifier
19541679
Citation
El-Hennawy AM, Abd-Elwahab AM, Abd-Elmaksoud AM, El-Ozairy HS, Boulis SR. Addition of clonidine or dexmedetomidine to bupivacaine prolongs caudal analgesia in children. Br J Anaesth. 2009 Aug;103(2):268-74. doi: 10.1093/bja/aep159. Epub 2009 Jun 18.
Results Reference
background
PubMed Identifier
9404178
Citation
Findlow D, Aldridge LM, Doyle E. Comparison of caudal block using bupivacaine and ketamine with ilioinguinal nerve block for orchidopexy in children. Anaesthesia. 1997 Nov;52(11):1110-3. doi: 10.1111/j.1365-2044.1997.204-az0346.x.
Results Reference
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PubMed Identifier
23161357
Citation
Xiang Q, Huang DY, Zhao YL, Wang GH, Liu YX, Zhong L, Luo T. Caudal dexmedetomidine combined with bupivacaine inhibit the response to hernial sac traction in children undergoing inguinal hernia repair. Br J Anaesth. 2013 Mar;110(3):420-4. doi: 10.1093/bja/aes385. Epub 2012 Nov 15.
Results Reference
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PubMed Identifier
18088445
Citation
Konakci S, Adanir T, Yilmaz G, Rezanko T. The efficacy and neurotoxicity of dexmedetomidine administered via the epidural route. Eur J Anaesthesiol. 2008 May;25(5):403-9. doi: 10.1017/S0265021507003079. Epub 2007 Dec 19.
Results Reference
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PubMed Identifier
24671181
Citation
Wu HH, Wang HT, Jin JJ, Cui GB, Zhou KC, Chen Y, Chen GZ, Dong YL, Wang W. Does dexmedetomidine as a neuraxial adjuvant facilitate better anesthesia and analgesia? A systematic review and meta-analysis. PLoS One. 2014 Mar 26;9(3):e93114. doi: 10.1371/journal.pone.0093114. eCollection 2014.
Results Reference
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Caudal Bupivacaine vs Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Children
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