Caudal Combination of Dexamethasone and/or Dexmedetomidine to Bupivacaine in Pediatric Hypospadias Surgery

Caudal Block Clinical Trial

Official title:

Adjuncts to Caudal Block in Pediatrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03261921
• Other study ID #: N-43-2016
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2017
• Last updated: August 22, 2017
• Start date: June 5, 2016
• Est. completion date: July 7, 2017

Study information

• Verified date: August 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One of the most commonly used regional anesthetic techniques in pediatric surgeries is the caudal epidural block. Its main disadvantage remains the short duration of action. Hence, different additives have been used. Dexmedetomidine as an additive to the local anesthetic bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so is dexamethasone. The investigators aimed to study the effect of combining both additives in the duration of analgesia, decreasing side effects and decreasing anesthetic doses

Description:

Sixty three children scheduled for hypospadias randomized into 3 groups. Group I (n=21) (dexamethasone 0.1mg/kg+ 0.5ml/kg bupivacaine 0.25%), group II(n=21)( dexmedetomidine 0.01ug/kg+ 0.5ml/kg bupivacaine 0.25%)and groupIII(n=21)(dexamethasone0.1mg/kg+dexmedetomidine0.01ug/kg +0.5ml/kg bupivacaine 0.25%).intraoperative and postoperative hemodynamics were recorded. In PACU, MOPS scores and sedation scores were recorded at 30min,1,2,3,6and 12hrs. Also the time of first analgesic request was recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 7, 2017
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

1 - ASA I-II 2- Males only 3- Children aged from 1-6 years 4- Children scheduled for hypospadias surgery

Exclusion Criteria:

1. Contraindication to caudal anesthesia.

2. cardiovascular diseases.

3. drug allergy.

4. Type I diabetes.

5. Clotting disorders.

6. Mentally retarded children or those whose families did not approve inclusion in the study

Related Conditions & MeSH terms

• Caudal Block

Intervention

Drug:
• Dexamethasone
Dexamethasone is used peri -operatively mainly to prevent nausea and vomiting. Also epidural administration of dexamethasone prolong the postoperative analgesia and reduce analgesic needs
• Dexmedetomidine
Dexmedetomidine is an alpha 2 agonist which has sedative ,analgesic, opioid sparing effect and was proved to prolong the duration of postoperative analgesia when added to local anesthetics
• Bupivacaine
local anesthetic agent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of first request of analgesia	the time from caudal block to the first time to analgesic needs	12 hours
Primary	pain scores	the modified objective pain score	12 hours
Secondary	sedation score	ramsay sedation score at the time of pain	12 hours
Secondary	heart rates(beat/minute)	Intra-operative recording	3 hours.
Secondary	mean arterial pressure (mmhg)	Intra-operative recording	3 hours