Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children

Pain Clinical Trial

Official title:

Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children: A Randomised Controlled Double Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416063
• Other study ID #: Faculty of medicine-JU
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2015
• Last updated: April 8, 2015
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: April 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 dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.

Description:

Dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration of action of caudal block with a local anesthetic agent.But which route of administration of dexmedetomidine is the most beneficial remains unknown.

The investigators performed prospective randomized double-blind study to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after caudal bupivacaine in children undergoing infra-umbilical surgery.

75 children (ASAⅠorⅡ,aged 1-6 yr) undergoing infra-umbilical surgery were included in this study. Anesthesia was induced with sevoflurane via a facemask, followed by placement of a laryngeal mask airway. Anesthesia was maintained with sevoflurane 2-3% in oxygen-air.Then,caudal block was applied. Patients were randomly assigned in three groups. Group B-Dcau (n = 25): Caudal bupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group B-Div (n = 25): bupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group B(n = 25): bupivacaine 0.25% and 10 ml normal saline intravenous

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2014
• Est. primary completion date: October 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:

• Hypersensitivity to any local anesthetics

• Patient has history of allergy, intolerance, or reaction to dexmedetomidine

• Infections at puncture sites

• Bleeding diathesis

• Preexisting neurological disease

• Children with uncorrected cardiac lesions

• Children with heart 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

Intervention

Drug:
• Caudal Dexmedetomidine
Drug:Caudal bupivacaine 0.25% 1ml/kg Drug: Caudal dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline sevoflurane Induction and maintenance of anesthesia
• Intravenous dexmedetomidine
Drug:Caudal bupivacaine 0.25% 1ml/kg. Drug:Intravenous dexmedetomidine1 µg /kg in a total volume of 10 ml sevoflurane Induction and maintenance of anesthesia
• Placebo
Drug:Caudal bupivacaine 0.25% 1ml/kg Intravenous: Normal saline 10 ml sevoflurane Induction and maintenance of anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

References & Publications (7)

Al-Zaben KR, Qudaisat IY, Al-Ghanem SM, Massad IM, Al-Mustafa MM, Al-Oweidi AS, Abu-Halaweh SA, Abu-Ali HM, Saleem MM. Intraoperative administration of dexmedetomidine reduces the analgesic requirements for children undergoing hypospadius surgery. Eur J Anaesthesiol. 2010 Mar;27(3):247-52. doi: 10.1097/EJA.0b013e32833522bf. — View Citation

Fares KM, Othman AH, Alieldin NH. Efficacy and safety of dexmedetomidine added to caudal bupivacaine in pediatric major abdominal cancer surgery. Pain Physician. 2014 Sep-Oct;17(5):393-400. — View Citation

Guler G, Akin A, Tosun Z, Ors S, Esmaoglu A, Boyaci A. Single-dose dexmedetomidine reduces agitation and provides smooth extubation after pediatric adenotonsillectomy. Paediatr Anaesth. 2005 Sep;15(9):762-6. — View Citation

Kim NY, Kim SY, Yoon HJ, Kil HK. Effect of dexmedetomidine on sevoflurane requirements and emergence agitation in children undergoing ambulatory surgery. Yonsei Med J. 2014 Jan;55(1):209-15. doi: 10.3349/ymj.2014.55.1.209. — View Citation

Schnabel A, Reichl SU, Poepping DM, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of intraoperative dexmedetomidine for acute postoperative pain in children: a meta-analysis of randomized controlled trials. Paediatr Anaesth. 2013 Feb;23(2):170-9. doi: 10.1111/pan.12030. Epub 2012 Oct 9. Review. — View Citation

She YJ, Xie GT, Tan YH, Kuang XH, Yu GF, Lian GH, Song XR. A prospective study comparing the onset and analgesic efficacy of different concentrations of levobupivacaine with/without dexmedetomidine in young children undergoing caudal blockade. J Clin Anesth. 2015 Feb;27(1):17-22. doi: 10.1016/j.jclinane.2014.09.005. Epub 2014 Nov 21. — View Citation

Zhang C, Hu J, Liu X, Yan J. Effects of intravenous dexmedetomidine on emergence agitation in children under sevoflurane anesthesia: a meta-analysis of randomized controlled trials. PLoS One. 2014 Jun 16;9(6):e99718. doi: 10.1371/journal.pone.0099718. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first analgesic requirement	Time to first rescue medication. The time from end of surgery to the first requirement of postoperative analgesia,pain score =4	24 hours	No
Secondary	Postoperative behaviour scores	behaviour score 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	1 hour	No
Secondary	Blood pressure Perioperative blood pressure readings	Perioperative blood pressure readings	2 hours	No
Secondary	Heart Rate	Perioperative heart rate readings	2 hours	No
Secondary	the incidence of emergence agitation	Participants will be followed for the duration of PACU stay, an expected average of 2 hours	2 hours	No
Secondary	Postoperative pain scores	postoperative pain score will be assessed over 24 hours	24 hours	No
Secondary	Side effects	side effects including nausea, vomiting and urinary retention and lower limb weakness	24 hours	Yes