Comparison of Doses of Dexmedetomidine With Bupivacaine in Caudal Block for Duration of Analgesia in Paediatric Infraumblical Surgeries.

NCT04700228 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2021-01-07

No results posted yet for this study

Summary

Various methods are used to control post-operative pain among children. Amongst these methods, caudal block is one of the most favoured, prominent and dependable methods for providing reliable analgesia in surgeries below umbilicus.

This study is to compare two doses of Dexmedetomidine added as adjunct to local anaesthesia using reduced dose in caudal block for prolonging the duration of analgesia. Our secondary outcomes will include blood pressure, heart rate, urinary retention, nausea and vomiting in the paediatric population.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Bupivacaine Hydrochloride

We are going to see the effects of dexmedetomidine as an adjunct to bupivacaine in caudal block. In first (control) group (group C) only bupivacaine will be given. Group BD1 patients will be given bupivacaine plus 1mcg/kg dexmedetomidine. Group BD2 patients will get bupivacaine plus 0.5mcg/kg dexmedetomidine. All the groups will be given a volume of 0.5ml/kg.

DRUG

Dexmedetomidine

We are going to see the effects of dexmedetomidine as an adjunct to bupivacaine in caudal block. In first (control) group (group C) only bupivacaine will be given. Group BD1 patients will be given bupivacaine plus 1mcg/kg dexmedetomidine. Group BD2 patients will get bupivacaine plus 0.5mcg/kg dexmedetomidine. All the groups will be given a volume of 0.5ml/kg.

Sponsors & Collaborators

  • Dr. Ruth K.M. Pfau Civil Hospital, Karachi

    lead OTHER_GOV

Principal Investigators

  • Haris Chohan, FCPS Pakistan · Dr. Ruth KM Pfau Civil Hospital, Dow University of Health Sciences Karachi, Pakistan

  • Syed Farjad Sultan, FCARCSI, PhD · Dr. Ruth KM Pfau Civil Hospital, Dow University of Health Sciences Karachi, Pakistan

  • Arun Kumar, FCPS · Dr. Ruth KM Pfau Civil Hospital, Dow University of Health Sciences, Karachi, Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-28
Primary Completion
2021-06-30
Completion
2021-09-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04700228 on ClinicalTrials.gov