Anesthesia, LocalNCT04445636
Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia.
A study testing Dexmedetomidine and Morphine in people with Anesthesia, Local, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the duration of postoperative analgesia, and any side effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in pediatric patients undergoing thoracic surgeries. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Dexmedetomidine and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jun 2020to 10 Dec 2020
- Phase
- Interventional
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I, II, III.
- Patients undergoing lung cyst excision.
- Patients undergoing Patent Ductus Arteriosus ligation.
Who cannot join
- Preoperative mechanical ventilation.
- Preoperative inotropic support
- History of mental retardation or delayed development that may interfere with pain intensity assessment
- Known or suspected coagulopathy,
- Any congenital anomalies of the sacrum or any infection at the site of injection.
- Known or suspected allergy to any of the studied drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia for Pediatric Thoracic Surgeries. A Randomized Controlled Trial.
The aim of this study is to compare the duration of postoperative analgesia, and any side effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in pediatric patients undergoing thoracic surgeries.
Read the detailed description
The patients will be randomized in a blinded fashion to get enrolled into 2 equal groups: Group A patients (n =25) will receive caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas Group B patients (n = 25) will receive caudal epidural analgesia using morphine with bupivacaine.
Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.
- Conditions
- Anesthesia, Local
- Being tested
- Dexmedetomidine, Morphine
- Keywords
- thoracic surgeries, pediatric caudal, dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Caudal block with Dexametomedine as an adjuvant to bupivacaine.
MorphineDrug
Addition of morphine as adjuvant to bupivacaine during caudal block.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | A group which will receive dexamedetomidine as an adjunct to bupivacaine used in caudal anesthesia. Receives: Drug: Dexmedetomidine |
| Morphine group | Experimental | A group which will receive morphine as an adjunct to bupivacaine used in caudal anesthesia. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative analgesia in hours.
Duration of postoperative analgesia in hours.
Measured: 3 months
Secondary outcomes (4)
Opioid consumption in the first 24 hours post- operative.
Opioid consumption in the first 24 hours post- operative.
Measured: 3 months
The duration of ICU stay in days
The duration of ICU stay in days
Measured: 3 months
Pain score FLACC from 0 to 6
Pain score FLACC from 0 to 6
Measured: 3 months
Post operative heart rate
Postoperative heart rate in beat per minute
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start28 Jun 2020
- Primary completion1 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelaziz Ismail, Cairo University
- Investigators
- AHMED ISMAIL, Lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445636
- Sponsor's protocol ID
- N239-2020
- Status last verified
- Dec 2020
- First submitted
- 21 Jun 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patients data are confidential
Publications
Anand VG, Kannan M, Thavamani A, Bridgit MJ. Effects of dexmedetomidine added to caudal ropivacaine in paediatric lower abdominal surgeries. Indian J Anaesth. 2011 Jul;55(4):340-6. doi: 10.4103/0019-5049.84835.
PubMed 22013248El Shamaa HA, Ibrahim M. A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery. Saudi J Anaesth. 2014 Apr;8(2):155-60. doi: 10.4103/1658-354X.130677.
PubMed 24843324Nguyen KN, Byrd HS, Tan JM. Caudal analgesia and cardiothoracic surgery: a look at postoperative pain scores in a pediatric population. Paediatr Anaesth. 2016 Nov;26(11):1060-1063. doi: 10.1111/pan.12990. Epub 2016 Aug 23.
PubMed 27550555
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia for Pediatric Thoracic Surgeries. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04445636
- Acronym / sponsor ID
- N239-2020
- Conditions
- Anesthesia, Local
- Keywords
- thoracic surgeries, pediatric caudal, dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Jun 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 24 Jun 2020 (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.
The aim of this study is to compare the duration of postoperative analgesia, and any side effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in pediatric patients undergoing thoracic surgeries.
Detailed description
The patients will be randomized in a blinded fashion to get enrolled into 2 equal groups: Group A patients (n =25) will receive caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas Group B patients (n = 25) will receive caudal epidural analgesia using morphine with bupivacaine.
Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineA group which will receive dexamedetomidine as an adjunct to bupivacaine used in caudal anesthesia. |
| Morphine group | Experimental | Drug: MorphineA group which will receive morphine as an adjunct to bupivacaine used in caudal anesthesia. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I, II, III.
- Patients undergoing lung cyst excision.
- Patients undergoing Patent Ductus Arteriosus ligation.
Key exclusion criteria (6 listed)
- Preoperative mechanical ventilation.
- Preoperative inotropic support
- History of mental retardation or delayed development that may interfere with pain intensity assessment
- Known or suspected coagulopathy,
- Any congenital anomalies of the sacrum or any infection at the site of injection.
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexCaudal block with Dexametomedine as an adjuvant to bupivacaine. | Drug | Dexmedetomidine group |
| MorphineAddition of morphine as adjuvant to bupivacaine during caudal block. | Drug | Morphine group |
Primary outcome
Duration of postoperative analgesia in hours.
Time frame: 3 months
Duration of postoperative analgesia in hours.
4 secondary outcomes
Opioid consumption in the first 24 hours post- operative.
Time frame: 3 months
The duration of ICU stay in days
Time frame: 3 months
Pain score FLACC from 0 to 6
Time frame: 3 months
Post operative heart rate
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Background: PubMed 22013248Anand VG, Kannan M, Thavamani A, Bridgit MJ. Effects of dexmedetomidine added to caudal ropivacaine in paediatric lower abdominal surgeries. Indian J Anaesth. 2011 Jul;55(4):340-6. doi: 10.4103/0019-5049.84835.
- Background: PubMed 24843324El Shamaa HA, Ibrahim M. A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery. Saudi J Anaesth. 2014 Apr;8(2):155-60. doi: 10.4103/1658-354X.130677.
- Background: PubMed 27550555Nguyen KN, Byrd HS, Tan JM. Caudal analgesia and cardiothoracic surgery: a look at postoperative pain scores in a pediatric population. Paediatr Anaesth. 2016 Nov;26(11):1060-1063. doi: 10.1111/pan.12990. Epub 2016 Aug 23.
- Individual participant dataSharing planned: No. The patients data are confidential
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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.
AHMED ISMAIL, Lecturer study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Morphine in people with Anesthesia, Local, run by Cairo 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 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: finished, as of the sponsor's last update on 22 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of postoperative analgesia in hours. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04445636, which also lists 3 linked publications.
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 22 Dec 2020.