AppendectomyNCT07088900
The Effectiveness of Dexmedetomidine as an Adjuvant for Bupivacaine Caudal Block in Pediatric Open Appendectomy Under General Anesthesia
A study testing caudal block using dexmedetomidine with bupivacaine and caudal block with bupivacaine in people with Appendectomy and Pediatric, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to evaluate if adding dexmedetomidine to bupivacaine in a caudal block can provide longer and better quality pain relief for children after open appendectomy surgery. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Appendectomy, Pediatric
- What is being tested?
- caudal block using dexmedetomidine with bupivacaine and caudal block with bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA (American Society of Anesthesiologists) physical status I or II.
- Legal guardian provides written informed consent. Exclusion Criteria
- Refusal of participation by the legal guardian.
- Known allergy or hypersensitivity to local anesthetics or dexmedetomidine.
- Coagulation disorder or receiving anticoagulant therapy.
- Active infection at or near the injection site.
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- Significant anatomical abnormalities of the lumbosacral spine.
- Pre-existing neurological disorders, psychiatric disorders, or a history of convulsions.
- Anticipated surgery time of more than 2.5 hours.
- Patients with severe asthma or active wheezing.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams university hospitals
Cairo
Dr fathy Tash, REC-FMASU@med.asu.eg, REC-FMASU@med.asu.eg
About this study
This study aims to evaluate if adding dexmedetomidine to bupivacaine in a caudal block can provide longer and better quality pain relief for children after open appendectomy surgery. The study will also assess the effect of this combination on the quality of recovery, including the incidence of emergence delirium, and its overall safety profile.
- Conditions
- Appendectomy, Pediatric
- Being tested
- caudal block using dexmedetomidine with bupivacaine, caudal block with bupivacaine
- Keywords
- caudal, dexmedetomidine, open appendectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal block using dexmedetomidine with bupivacaineProcedure or surgery
Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 µg/kg of dexmedetomidine (diluted in 1 mL of normal saline).
caudal block with bupivacaineProcedure or surgery
Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 mL of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 mL of normal saline. Receives: Procedure: caudal block with bupivacaine |
| Experimental Group | Experimental | Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 µg/kg of dexmedetomidine (diluted in 1 mL of normal saline). Receives: Procedure: caudal block using dexmedetomidine with bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Rescue Analgesia:
Defined as the time interval in minutes from the performance of the caudal block until the first administration of rescue analgesia (ibuprofen), which is prompted by a FLACC pain score of ≥ 4.
Measured: Up to 24 hours post-caudal block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendectomyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Tarek Hussein, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088900
- Sponsor's protocol ID
- FMASU MD352a/2023/2025
- Status last verified
- Apr 2026
- First submitted
- 20 Jul 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dexmedetomidine as an Adjuvant for Bupivacaine Caudal Block in Pediatric Open Appendectomy Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07088900
- Acronym / sponsor ID
- FMASU MD352a/2023/2025
- Conditions
- Appendectomy, Pediatric
- Keywords
- caudal, dexmedetomidine, open appendectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate if adding dexmedetomidine to bupivacaine in a caudal block can provide longer and better quality pain relief for children after open appendectomy surgery. The study will also assess the effect of this combination on the quality of recovery, including the incidence of emergence delirium, and its overall safety profile.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: caudal block with bupivacainePatients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 mL of normal saline. |
| Experimental Group | Experimental | Procedure: caudal block using dexmedetomidine with bupivacainePatients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 µg/kg of dexmedetomidine (diluted in 1 mL of normal saline). |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- ASA (American Society of Anesthesiologists) physical status I or II.
- Legal guardian provides written informed consent. Exclusion Criteria
- Refusal of participation by the legal guardian.
- Known allergy or hypersensitivity to local anesthetics or dexmedetomidine.
- Coagulation disorder or receiving anticoagulant therapy.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caudal block using dexmedetomidine with bupivacainePatients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 µg/kg of dexmedetomidine (diluted in 1 mL of normal saline). | Procedure or surgery | Experimental Group |
| caudal block with bupivacainePatients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 mL of normal saline | Procedure or surgery | Control Group |
Primary outcome
Time to First Rescue Analgesia:
Time frame: Up to 24 hours post-caudal block
Defined as the time interval in minutes from the performance of the caudal block until the first administration of rescue analgesia (ibuprofen), which is prompted by a FLACC pain score of ≥ 4.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caudal block using dexmedetomidine with bupivacaine and caudal block with bupivacaine in people with Appendectomy and Pediatric, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Rescue Analgesia: (time frame: Up to 24 hours post-caudal block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.