Caudal Bupivacaine vs Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Children
NCT ID: NCT02385435
Last Updated: 2015-03-11
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
91 participants
INTERVENTIONAL
2014-01-31
2014-08-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bupivacaine
single shot caudal plain bupivacaine at a dose of 2mg/kg is used as a reference control drug.
Bupivacaine
Caudal Bupivacaine 2 mg/kg single shot
dexmedetomidine 1μg.kg-1
Single shot Caudal dexmedetomidine 1μg.kg-1 used as the second arm intervention
dexmedetomidine 1μg.kg-1
Caudal dexmedetomidine 1μg.kg-1, single shot
dexmedetomidine 2μg.kg-1
Single shot Caudal dexmedetomidine 2 μg.kg-1 used as the second arm intervention
dexmedetomidine 2μg.kg-1
Caudal dexmedetomidine 2μg.kg-1, single shot
Interventions
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Bupivacaine
Caudal Bupivacaine 2 mg/kg single shot
dexmedetomidine 1μg.kg-1
Caudal dexmedetomidine 1μg.kg-1, single shot
dexmedetomidine 2μg.kg-1
Caudal dexmedetomidine 2μg.kg-1, single shot
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for lower abdominal and perineal surgery
* Under general anesthesia
Exclusion Criteria
* 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
1 Year
6 Years
ALL
No
Sponsors
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University of Jordan
OTHER
Responsible Party
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Khaled Radian Al-zaben
Dr
Principal Investigators
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khaled R Al-zaben
Role: PRINCIPAL_INVESTIGATOR
University of Jordan
Ibraheem Y Qudaisat
Role: STUDY_DIRECTOR
University of Jordan
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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University of jordan
Identifier Type: -
Identifier Source: org_study_id
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