PCANCT05688371
Dexmedetomidine Plus Low Dose Morphine Versus Standard Dose of Morphine in PCA in Children .
A study testing standard dose morphine and low dose morphine plus dexmedetomidine in people with PCA and Children, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The treatment of perioperative pain in children has been a topic of great interest to pediatricians, pediatric surgeons, and anesthesiologists for many years. Opioids are the most common analgesics used to manage acute postoperative pain in children and adults Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- PCA, Children, Dexmedetomidine
- What is being tested?
- standard dose morphine and low dose morphine plus dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Oct 2024
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I \& II of both sex.
- Age between 8 and 12 years.
- Patients scheduled for exploration surgery under general anesthesia.
Who cannot join
- Parents refused to give consent.
- Patients with history of allergy to morphine or dexmedetomidine.
- Mental disorders.
- Unsuitability for extubation.
- Comorbidities as cardiac, pulmonary and obstructive sleep apnea.
- children with chronic opioid use for > 3 monthes
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Benisuef University Hospital
Egypt
Mariana AbdElsayed Mansour, MD, 01222960009, mrmrsyk4@gmail.com
About this study
Official title: Comparison of Addition of Dexmedetomidine to Low Dose Morphine Versus Standard Dose of Morphine in Patiant Controlled Analgesia in Children Undergoing Pelvi Abdominal Exploration. a Prospective Randomized Trial
The treatment of perioperative pain in children has been a topic of great interest to pediatricians, pediatric surgeons, and anesthesiologists for many years. Opioids are the most common analgesics used to manage acute postoperative pain in children and adults
Read the detailed description
Patient-controlled analgesia (PCA) permits patients to self-administer small doses of opioid analgesics intravenously or subcutaneously at frequent intervals. PCA is used in the management of moderate-to-severe pain. Patient-controlled analgesia (PCA) is now used in children as young as 5 yr for the treatment of postoperative pain.
- Conditions
- PCA, Children, Dexmedetomidine, Morphine
- Being tested
- standard dose morphine, low dose morphine plus dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard dose morphineDrug
Also called morphine sulphate
Receiving 0.05 mg morphine/kg as a bolus.
low dose morphine plus dexmedetomidineDrug
Also called precedex
Receiving 0.02 mg morphine/kg as a bolus dose + 0.2 microgram/kg dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| standard dose morphine | Active comparator | children will receive 0.05 mg morphine /kg.as a bolus dose dissolved in 50 ml normal saline and 10 microgram/kg continuous infusion Receives: Drug: standard dose morphine |
| low dose morphine and dexmedetomidine | Active comparator | children will receive 0.02 mg morphine /kg bolus dose plus 0.2 µg/kg dexmedetomidine dissolved in 50 ml normal saline and10 microgram/kg continuous infusion . Receives: Drug: low dose morphine plus dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain intensity evaluation at (0,1, 2,6,12, 24h).
visual analogue score consists of a straight 10 cm line with the end points defining extreme limits between (0) no pain and (10) worst pain, the score is determined by measuring the distance between no pain and worst pain.
Measured: 24 hour
Secondary outcomes (4)
Total morphine consumption in 24h postoperative.
total morphine dose in 24h
Measured: 24 hour
sedation
(0 = awake; 1 = drowsy; 2 = asleep but arousable; 3 = deeply asleep). Patients were considered sedated if they had a sedation score of more than 0.
Measured: 24 hour
respiratory depression
respiratory depression, if respiratory rate less than 10 breaths/minute
Measured: 24 hour
nausea vomiting
Nausea and vomiting was recorded using a categorical scoring system (0 = none, 1 = nausea, 2 = retching, 3 = vomiting).
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCAStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Soliman, Beni-Suef University
- Investigators
- Mariana abdelsayed Mansour, Lecturer, Principal investigator, Benisuef university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688371
- Sponsor's protocol ID
- Mariana AbdElsayed Mansour
- Status last verified
- Mar 2024
- First submitted
- 25 Dec 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Addition of Dexmedetomidine to Low Dose Morphine Versus Standard Dose of Morphine in Patiant Controlled Analgesia in Children Undergoing Pelvi Abdominal Exploration. a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05688371
- Acronym / sponsor ID
- Mariana AbdElsayed Mansour
- Conditions
- PCA, Children, Dexmedetomidine, Morphine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 18 Jan 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.
The treatment of perioperative pain in children has been a topic of great interest to pediatricians, pediatric surgeons, and anesthesiologists for many years. Opioids are the most common analgesics used to manage acute postoperative pain in children and adults
Detailed description
Patient-controlled analgesia (PCA) permits patients to self-administer small doses of opioid analgesics intravenously or subcutaneously at frequent intervals. PCA is used in the management of moderate-to-severe pain. Patient-controlled analgesia (PCA) is now used in children as young as 5 yr for the treatment of postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard dose morphine | Active comparator | Drug: standard dose morphinechildren will receive 0.05 mg morphine /kg.as a bolus dose dissolved in 50 ml normal saline and 10 microgram/kg continuous infusion |
| low dose morphine and dexmedetomidine | Active comparator | Drug: low dose morphine plus dexmedetomidinechildren will receive 0.02 mg morphine /kg bolus dose plus 0.2 µg/kg dexmedetomidine dissolved in 50 ml normal saline and10 microgram/kg continuous infusion . |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I \& II of both sex.
- Age between 8 and 12 years.
- Patients scheduled for exploration surgery under general anesthesia.
Key exclusion criteria (6 listed)
- Parents refused to give consent.
- Patients with history of allergy to morphine or dexmedetomidine.
- Mental disorders.
- Unsuitability for extubation.
- Comorbidities as cardiac, pulmonary and obstructive sleep apnea.
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 |
|---|---|---|
| standard dose morphineAlso: morphine sulphateReceiving 0.05 mg morphine/kg as a bolus. | Drug | standard dose morphine |
| low dose morphine plus dexmedetomidineAlso: precedexReceiving 0.02 mg morphine/kg as a bolus dose + 0.2 microgram/kg dexmedetomidine | Drug | low dose morphine and dexmedetomidine |
Primary outcome
Post-operative pain intensity evaluation at (0,1, 2,6,12, 24h).
Time frame: 24 hour
visual analogue score consists of a straight 10 cm line with the end points defining extreme limits between (0) no pain and (10) worst pain, the score is determined by measuring the distance between no pain and worst pain.
4 secondary outcomes
Total morphine consumption in 24h postoperative.
Time frame: 24 hour
sedation
Time frame: 24 hour
respiratory depression
Time frame: 24 hour
nausea vomiting
Time frame: 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
Related trials for PCA
Recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
Not yet recruiting
ESP Versus SPSIP Block for Pain Relief After Shoulder Arthroscopy
Postoperative Pain
Active, not recruiting
Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device
Prostate, Cancer
Active, not recruitingPhase 3
PSMA PET Combined With MRI for the Detection of PCa
PCA, Prostate Cancer
Not yet recruiting
Quadro-Iliac Plane Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia Repair
Inguinal Hernia Unilateral, Postoperative Pain
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.
Mariana abdelsayed Mansour, Lecturer principal investigator
Benisuef university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard dose morphine and low dose morphine plus dexmedetomidine in people with PCA and Children, run by Beni-Suef 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: status not confirmed, as of the sponsor's last update on 25 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariana abdelsayed Mansour, MD (01222960009, mrmrsyk4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain intensity evaluation at (0,1, 2,6,12, 24h). (time frame: 24 hour). 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 25 Sep 2024.