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CompletedNCT03307590Updated Jul 17, 2018

Comparing Dexmedetomidine With Bupivacaine Versus Bupivacaine Alone for Caudal Block in Supra - Umbilical Surgeries

A Phase 2/3 interventional study of Dexmedetomidine and Bupivacaine in Anesthesia, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2018-07-17.

Sponsored by Cairo University · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
1 Year to 6 Years
Sex
All
01

Study summary

dexmedetomidine is an alpha 2 adrenergic receptor agonist that is given either systemically or combined to local anesthetics during regional blocks. Investigators studied the combination of dexmedetomedine/bupivacaine versus bupivacaine alone for caudal blockage in pediatric patients undergoing supra - umbilical surgeries.

Read the detailed description

Dexmedetomidine was combined to bupivavaine and administered via caudal route to be compared to caudal bupivavaine alone for analgesia following upper trunk surgery

02

Conditions studied

  • Anesthesia
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • supra - umbilical surgeries

Exclusion criteria

Exclusion Criteria:

  • allergy to the drug or coagulopathy
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    D group

    Dexmedetomidine with bupivacaine group Caudal dexmedetomidine 1.5 microgram/kg with bupivavaine (0.25%) 1.25 ml/kg were administered

    Drug: Dexmedetomidine

  • Active comparator
    B group

    Bupivacaine only group Caudal bupivavaine (0.25%) 1.25 ml/kg without dexmedetomidine was administered

    Drug: Bupivacaine

Interventions

  • Caudal block by dexmedetomidine and bupivavaine

    Also known as: Precedex

  • Caudal block by bupivavaine alone

    Also known as: Marcaine

06

What researchers measure

Primary outcomes

  1. Pain relief

    CHEOPS scale value

    Time frame: 6 months study

07

Study locations

1 site
  • Cairo University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03307590
Lead sponsor
Cairo University
Responsible party
Ahmed Kareem (Anesthesiologist, Cairo University) — Principal investigator
First posted
Oct 11, 2017
Start date
Oct 1, 2017
Primary completion
Dec 30, 2017
Completion
Dec 30, 2017
Last update
Jul 17, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Dexmedetomidine · Bupivacaine

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