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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385435
• Other study ID #: University of jordan
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 24, 2015
• Last updated: March 10, 2015
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Jordanian Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

References & Publications (9)

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. — View 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. — View 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. — View 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. Epub 2007 Dec 19. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first analgesic requirement	The time from end of surgery to the first requirement of postoperative analgesia	24 hours	No
Primary	Postoperative pain scores		24 hours	No
Primary	Number of postoperative analgesia doses	Number of paracetamol doses needed by each patient	24 hours	No
Secondary	Postoperative sedation scores	Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals.	2 hours	No
Secondary	Sevoflurane concentration	Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60%.	intraoperative	No
Secondary	Blood pressure	Intraoperative blood pressure readings	intraoperative	Yes
Secondary	Heart Rate	Intraoperative heart rate readings	intraoperative	No
Secondary	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).	24 hours	Yes