Pain in Pediatric PatientsPhase 4NCT03460041
Caudal Dexmetedomedine Versus Magnesium in Orthopedic Pediatric Surgeries
A Phase 4 study testing Magnesium Sulfate, Dexmetedomedine and Bupivacaine in people with Pain in Pediatric Patients, run by Hagar hassanein refaee at 1 site in Egypt.
Trial summary
This study will be performed in Abo Elreesh Pediatric Hospital / Cairo University after obtaining approval by the University Ethics Committee, and a written informed consent from the parents or guardians. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Pain in Pediatric Patients
- What is being tested?
- Magnesium Sulfate, Dexmetedomedine and Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 15 Mar 2018
- 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
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 1 - 7 years old.
- American Society of Anesthesiologist (ASA) physical status class I- II.
- Patients scheduled for infra-umbilical orthopedic surgeries.
Who cannot join
- Patients with known allergy to the study drugs
- Suspected coagulopathy.
- Infection at the site of caudal block.
- History of developmental delay or neuromuscular disorders.
- Skeletal deformities.
- Patients on magnesium therapy
Trial locations and contacts
1 site in 1 country.
Mai Ahmed Aly, Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo University faculty
Cairo
Cairo University
About this study
This study will be performed in Abo Elreesh Pediatric Hospital / Cairo University after obtaining approval by the University Ethics Committee, and a written informed consent from the parents or guardians.
Thirty six patients will be randomly assigned using an online randomization program (http://www.randomizer.org) and the sealed envelope method into three groups: Group D (n=12): Dexmetedomidine group. 0.5 ml of dexmetedomidine (2 μg/kg) added to bupivacaine, Group M (n=12) : Magnesium group.0.5 ml of magnesium sulphate (50 mg) added to bupivacaine, Group C (n=12) :Control group.bupivacaine 0.25% diluted in normal saline with total volume of 1 ml/kg.
Read the detailed description
History regarding previous anesthesia, surgery, any significant medical illness, medications and allergy will be taken for all children who will be enrolled in the study. Complete physical examination and airway assessment will be done. Hemoglobin percentage, blood sugar and coagulation profile will be investigated preoperatively Sedation will be done by giving midazolam (0.2 mg/kg IM).On arrival to the operating room all patients will be monitored by 5 leads electrocardiography (ECG), automated non-invasive blood pressure monitoring (NIBP), and pulse oximetery.
Inhalational induction of anesthesia will be achieved by 8% sevoflurane in 100% oxygen and an appropriate-sized cannula will be inserted. Endotracheal intubation will be performed after which sevoflurane concentration will be reduced to 3%. After hemodynamic stabilization, caudal block will be performed by using beveled needle 18-23 G in the lateral decubitus position by using the loss of resistance technique. The study solutions will be injected caudally slowly with repetitive intermittent aspiration by an anesthesiologist blinded to the test drugs. The inhaled concentration of sevoflurane will be adjusted to achieve hemodynamic changes less than 30% of the preoperative values
Recorded Parameters for the study:
Intraoperative hemodynamic: heart rates (beats/minutes), mean arterial blood pressure (mmHg) after stabilization, before skin incision and every 15 minutes till the end of surgery.
Sedation score: Sedation will be monitored after PACU arrival using Ramsay score with its 0-6 score range.
Pain score (FLACC score) with its 0-10 score range, each patient pain intensity will be assessed at the end of surgery and 12 hours postoperatively.
Time of rescue analgesia (from the time of caudal injection to the time at which FLACC score 4 or more) will be recorded.
Complication secondary to test drugs in the form of toxicity like postoperative nausea and vomiting, respiratory depression, hematoma, bradycardia (HR <80 BPM) and hypotension (SBP <70 mmhg+ age in years * 2) and complication secondary to caudal block; infection, hematoma and pain at the site of injection will be recorded.
Total doses of rescue drugs will be calculated for each group.
- Conditions
- Pain in Pediatric Patients
- Being tested
- Magnesium Sulfate, Dexmetedomedine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
caudal magnesium sulphate added to bupivacaine for pain management
DexmetedomedineDrug
Caudal dexmetedomedine added to bupivacaine for pain management
BupivacaineDrug
Caudal bupivacaine for pain management
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Drug: Bupivacaine |
| Magnesium | Active comparator | Not described Receives: Drug: Magnesium Sulfate |
| Dexmetedomedine | Active comparator | Not described Receives: Drug: Dexmetedomedine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Comparing duration of analgesia between caudal magnesium and caudal dexmetedomedine using flacc score
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Dec 2017
- Primary completion15 Mar 2018 (estimated)
- Study completion15 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain in Pediatric PatientsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hagar hassanein refaee
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Hagar hassanein refaee, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460041
- Sponsor's protocol ID
- N-59-2017
- Status last verified
- Mar 2018
- First submitted
- 26 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Dexmetedomedine Versus Magnesium in Orthopedic Pediatric Surgeries
- ClinicalTrials.gov ID
- NCT03460041
- Acronym / sponsor ID
- N-59-2017
- Conditions
- Pain in Pediatric Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hagar hassanein refaeeUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 15 Mar 2018 (estimated)
- Study completion
- 15 Mar 2018 (estimated)
- First posted
- 9 Mar 2018 (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 will be performed in Abo Elreesh Pediatric Hospital / Cairo University after obtaining approval by the University Ethics Committee, and a written informed consent from the parents or guardians.
Thirty six patients will be randomly assigned using an online randomization program (http://www.randomizer.org) and the sealed envelope method into three groups: Group D (n=12): Dexmetedomidine group. 0.5 ml of dexmetedomidine (2 μg/kg) added to bupivacaine, Group M (n=12) : Magnesium group.0.5 ml of magnesium sulphate (50 mg) added to bupivacaine, Group C (n=12) :Control group.bupivacaine 0.25% diluted in normal saline with total volume of 1 ml/kg.
Detailed description
History regarding previous anesthesia, surgery, any significant medical illness, medications and allergy will be taken for all children who will be enrolled in the study. Complete physical examination and airway assessment will be done. Hemoglobin percentage, blood sugar and coagulation profile will be investigated preoperatively Sedation will be done by giving midazolam (0.2 mg/kg IM).On arrival to the operating room all patients will be monitored by 5 leads electrocardiography (ECG), automated non-invasive blood pressure monitoring (NIBP), and pulse oximetery.
Inhalational induction of anesthesia will be achieved by 8% sevoflurane in 100% oxygen and an appropriate-sized cannula will be inserted. Endotracheal intubation will be performed after which sevoflurane concentration will be reduced to 3%. After hemodynamic stabilization, caudal block will be performed by using beveled needle 18-23 G in the lateral decubitus position by using the loss of resistance technique. The study solutions will be injected caudally slowly with repetitive intermittent aspiration by an anesthesiologist blinded to the test drugs. The inhaled concentration of sevoflurane will be adjusted to achieve hemodynamic changes less than 30% of the preoperative values
Recorded Parameters for the study:
Intraoperative hemodynamic: heart rates (beats/minutes), mean arterial blood pressure (mmHg) after stabilization, before skin incision and every 15 minutes till the end of surgery.
Sedation score: Sedation will be monitored after PACU arrival using Ramsay score with its 0-6 score range.
Pain score (FLACC score) with its 0-10 score range, each patient pain intensity will be assessed at the end of surgery and 12 hours postoperatively.
Time of rescue analgesia (from the time of caudal injection to the time at which FLACC score 4 or more) will be recorded.
Complication secondary to test drugs in the form of toxicity like postoperative nausea and vomiting, respiratory depression, hematoma, bradycardia (HR <80 BPM) and hypotension (SBP <70 mmhg+ age in years * 2) and complication secondary to caudal block; infection, hematoma and pain at the site of injection will be recorded.
Total doses of rescue drugs will be calculated for each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Bupivacaine |
| Magnesium | Active comparator | Drug: Magnesium Sulfate |
| Dexmetedomedine | Active comparator | Drug: Dexmetedomedine |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 1 - 7 years old.
- American Society of Anesthesiologist (ASA) physical status class I- II.
- Patients scheduled for infra-umbilical orthopedic surgeries.
Key exclusion criteria (6 listed)
- Patients with known allergy to the study drugs
- Suspected coagulopathy.
- Infection at the site of caudal block.
- History of developmental delay or neuromuscular disorders.
- Skeletal deformities.
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 |
|---|---|---|
| Magnesium Sulfatecaudal magnesium sulphate added to bupivacaine for pain management | Drug | Magnesium |
| DexmetedomedineCaudal dexmetedomedine added to bupivacaine for pain management | Drug | Dexmetedomedine |
| BupivacaineCaudal bupivacaine for pain management | Drug | Control |
Primary outcome
Postoperative pain
Time frame: 12 hours
Comparing duration of analgesia between caudal magnesium and caudal dexmetedomedine using flacc score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Mai Ahmed Aly, Lecturer contact
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 Magnesium Sulfate, Dexmetedomedine and Bupivacaine in people with Pain in Pediatric Patients, run by Hagar hassanein refaee 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 3 inclusion and 6 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 9 Mar 2018. 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. Some participants in this study may receive a placebo. 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 Hagar Hassanein Refaee, Assistant lecturer (01063949855, bibo_gogo12@yahoo.Com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 12 hours). 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 9 Mar 2018.