Adding Dexmedetomidine to Caudal Bupivacaine for Analgesia in Supra - Umbilical Pediatric Surgeries: Would it Add More Analgesia

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



Sponsors

Lead Sponsor



Source

Cairo University

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No

Is Us Export

Yes


Brief 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.

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

Overall Status

Suspended

Start Date

2017-10-01

Completion Date

2017-12-30

Primary Completion Date

2017-12-30

Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Pain relief
6 months study

Enrollment

24

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

Caudal block by dexmedetomidine and bupivavaine

Arm Group Label

D group

Other Name

Precedex


Intervention Type

Drug

Intervention Name


Description

Caudal block by bupivavaine alone

Arm Group Label

B group

Other Name

Marcaine



Eligibility

Criteria

Inclusion Criteria:

- supra - umbilical surgeries

Exclusion Criteria:

- allergy to the drug or coagulopathy

Gender

All

Minimum Age

1 Year

Maximum Age

6 Years

Healthy Volunteers

No


Location

Facility

Cairo University
Cairo Egypt

Location Countries

Country

Egypt


Verification Date

2017-10-01

Lastchanged Date

2017-10-22

Firstreceived Date

2017-08-20

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Cairo University

Investigator Full Name

Ahmed Kareem

Investigator Title

Anesthesiologist


Has Expanded Access

No

Number Of Arms

2

Intervention Browse

Mesh Term

Bupivacaine

Dexmedetomidine



Arm Group

Arm Group Label

D group

Arm Group Type

Active Comparator

Description

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


Arm Group Label

B group

Arm Group Type

Active Comparator

Description

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



Firstreceived Results Date

N/A

Why Stopped

awaiting subjects and waiting for supply of the drug under investigation

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Prevention

Masking

None (Open Label)


Study First Submitted

August 20, 2017

Study First Submitted Qc

October 6, 2017

Study First Posted

October 11, 2017

Last Update Submitted

October 22, 2017

Last Update Submitted Qc

October 22, 2017

Last Update Posted

October 24, 2017


ClinicalTrials.gov processed this data on October 24, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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