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

NCT02385435 | Completed Phase 2 DMC

• 1 other identifier: University of jordan
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative

Keywords

caudal block

Outcome Measures

Primary Outcomes (3)

• Time to first analgesic requirement

  The time from end of surgery to the first requirement of postoperative analgesia

  24 hours

• Postoperative pain scores

  24 hours

• Number of postoperative analgesia doses

  Number of paracetamol doses needed by each patient

  24 hours

Secondary Outcomes (5)

• Postoperative sedation scores

  2 hours

• Sevoflurane concentration

  intraoperative

• Blood pressure

  intraoperative

• Heart Rate

  intraoperative

• Side effects of study drugs

  24 hours

Study Arms (3)

Bupivacaine

ACTIVE COMPARATOR

single shot caudal plain bupivacaine at a dose of 2mg/kg is used as a reference control drug.

Drug: Bupivacaine

dexmedetomidine 1μg.kg-1

ACTIVE COMPARATOR

Single shot Caudal dexmedetomidine 1μg.kg-1 used as the second arm intervention

Drug: dexmedetomidine 1μg.kg-1

dexmedetomidine 2μg.kg-1

ACTIVE COMPARATOR

Single shot Caudal dexmedetomidine 2 μg.kg-1 used as the second arm intervention

Drug: dexmedetomidine 2μg.kg-1

Interventions

Bupivacaine DRUG

Caudal Bupivacaine 2 mg/kg single shot

Also known as: Broup B

Bupivacaine

dexmedetomidine 1μg.kg-1 DRUG

Caudal dexmedetomidine 1μg.kg-1, single shot

Also known as: Group BD1

dexmedetomidine 1μg.kg-1

dexmedetomidine 2μg.kg-1 DRUG

Caudal dexmedetomidine 2μg.kg-1, single shot

Also known as: Group BD2

dexmedetomidine 2μg.kg-1

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jordan: lead

Related Publications (9)

• 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.

  PMID: 25203847 BACKGROUND

• 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.

  PMID: 24383602 BACKGROUND

• 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.

  PMID: 25040840 BACKGROUND

• 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.

  PMID: 19076110 BACKGROUND

• 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.

  PMID: 19541679 BACKGROUND

• 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.

  PMID: 9404178 BACKGROUND

• 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.

  PMID: 23161357 BACKGROUND

• 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.

  PMID: 18088445 BACKGROUND

• 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.

  PMID: 24671181 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• khaled R Al-zaben

  University of Jordan

  PRINCIPAL INVESTIGATOR

• Ibraheem Y Qudaisat

  University of Jordan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 11, 2015
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 11, 2015

Record last verified: 2015-03