Preemptive AnalgesiaPhase 4NCT05837000
Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair
A Phase 4 study testing Dexmedetomidine, Ketamine and Magnesium sulphate in people with Preemptive Analgesia and Dexmedetomidine, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients Ketamine is a selective antagonist of N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. Read more about this study
- Who is it for?
- Ages 1 year to 7 years, men only
- Conditions the study is for
- Preemptive Analgesia, Dexmedetomidine, Ketamine
- What is being tested?
- Dexmedetomidine, Ketamine and Magnesium sulphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2023to 25 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 1 year to 7 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Aged 1-7 years
- American Society of Anesthesiologists (ASA) classification I and II, undergoing hypospadias repair.
Who cannot join
- Developmental delay
- Psychological or neurological disorders
- Difficult airway
- Hyperactive airway disease or children in whom caudal block was contraindicated (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Karelsheikh University Hospital
Kafr ash Shaykh, Karelsheikh, 33516
Gamal H Shams, MD, 00201095927971, gamal.shams@yahoo.com
About this study
Official title: Role of Adding Dexmedetomidine, Ketamine and Magnesium Sulphate to Caudal Block as Preemptive Analgesia in Hypospadias Repair in Pediatrics: a Randomized Double-blinded Trial
Caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients Ketamine is a selective antagonist of N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.
- Conditions
- Preemptive Analgesia, Dexmedetomidine, Ketamine, Magnesium Sulphate, Hypospadias, Pediatrics
- Being tested
- Dexmedetomidine, Ketamine, Magnesium sulphate
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patient will receive 0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
KetamineDrug
Patient will receive 0.5ml/kg bupivacaine 0.25% + 0.5mg/kg ketamine caudally
Magnesium sulphateDrug
Patient will receive 0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally Receives: Drug: Dexmedetomidine |
| Ketamine | Experimental | 0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally Receives: Drug: Ketamine |
| Magnesium sulphate | Experimental | 0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally. Receives: Drug: Magnesium sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
First time of rescue analgesia requirement
If the FLACC score is ≥ 4, pethidine 1 mg/kg. The first time to require analgesia will be calculated (the time from caudal block to the first time to pethidine injection).
Measured: 24 hours postoperatively
Secondary outcomes (3)
Total consumption of rescue analgesia
If the FLACC score is ≥ 4, pethidine 1 mg/kg. The total pethidine consumption of patients require analgesia in the first 24 h postoperative will be calculated.
Measured: 24 hours postoperatively
Pain score
FLACC scale will used for postoperative pain assessment. This scale ranges from 0 to 10 where 0 represents no pain and 10 represents worst possible pain
Measured: 24 hours postoperatively
The incidence of adverse effects
Hypotension bradycardia, respiratory depression and vomiting will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start15 May 2023
- Primary completion25 Oct 2024 (estimated)
- Study completion25 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preemptive AnalgesiaStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamal Hendawy Shams, Kafrelsheikh University
- Investigators
- Kafrelsheikh University, Principal investigator, Research ethics committee - Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837000
- Sponsor's protocol ID
- MKSU 51- 2 - 16
- Status last verified
- Jun 2023
- First submitted
- 19 Apr 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon Reasonable request from the corresponding author for one year after study completion
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Adding Dexmedetomidine, Ketamine and Magnesium Sulphate to Caudal Block as Preemptive Analgesia in Hypospadias Repair in Pediatrics: a Randomized Double-blinded Trial
- ClinicalTrials.gov ID
- NCT05837000
- Acronym / sponsor ID
- MKSU 51- 2 - 16
- Conditions
- Preemptive Analgesia, Dexmedetomidine, Ketamine, Magnesium Sulphate, Hypospadias, Pediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 25 Oct 2024 (estimated)
- Study completion
- 25 Oct 2024 (estimated)
- First posted
- 1 May 2023 (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.
Caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients Ketamine is a selective antagonist of N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally |
| Ketamine | Experimental | Drug: Ketamine0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally |
| Magnesium sulphate | Experimental | Drug: Magnesium sulphate0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged 1-7 years
- American Society of Anesthesiologists (ASA) classification I and II, undergoing hypospadias repair.
Key exclusion criteria (4 listed)
- Developmental delay
- Psychological or neurological disorders
- Difficult airway
- Hyperactive airway disease or children in whom caudal block was contraindicated (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).
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 |
|---|---|---|
| DexmedetomidinePatient will receive 0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally | Drug | Dexmedetomidine |
| KetaminePatient will receive 0.5ml/kg bupivacaine 0.25% + 0.5mg/kg ketamine caudally | Drug | Ketamine |
| Magnesium sulphatePatient will receive 0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally. | Drug | Magnesium sulphate |
Primary outcome
First time of rescue analgesia requirement
Time frame: 24 hours postoperatively
If the FLACC score is ≥ 4, pethidine 1 mg/kg. The first time to require analgesia will be calculated (the time from caudal block to the first time to pethidine injection).
3 secondary outcomes
Total consumption of rescue analgesia
Time frame: 24 hours postoperatively
Pain score
Time frame: 24 hours postoperatively
The incidence of adverse effects
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon Reasonable request from the corresponding author for one year after study completion
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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. This study is not recruiting at the moment.
Kafrelsheikh University principal investigator
Research ethics committee - Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Ketamine and Magnesium sulphate in people with Preemptive Analgesia and Dexmedetomidine, run by Kafrelsheikh 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Jun 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamal MD Hendawy Shams, MD (00201095927971, gamal.shams@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First time of rescue analgesia requirement (time frame: 24 hours postoperatively). 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 13 Jun 2023.