Major Abdominal SurgeriesNCT03158584
Effect of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries,
A study testing Intrathecal Morphine in people with Major Abdominal Surgeries, run by Assiut University at 1 site in Egypt.
Trial summary
safety and efficacy of intrathecal morphine in post operative pain relief in pediatric patients undergoing major abdominal cancer surgeries using different doses of intrathecal morphine (2 μg/kg , 5 μg/kg ,10 μg/kg). Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Major Abdominal Surgeries
- What is being tested?
- Intrathecal Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 1 Jul 2017
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- weight between 10-30 kg ,
- American Society of Anesthesiologists (ASA) I - II
- major abdominal surgeries
Who cannot join
- Children with sacral bone abnormalities
- spina bifida
- coagulopathy
- mental delay or retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries, Dose-finding Clinical Study
safety and efficacy of intrathecal morphine in post operative pain relief in pediatric patients undergoing major abdominal cancer surgeries using different doses of intrathecal morphine (2 μg/kg , 5 μg/kg ,10 μg/kg).
Read the detailed description
After obtaining approval of the local ethics committee of faculty of medicine, Assiut University , Assiut , Egypt , and parent's written informed consent, This randomized double -blinded prospective study conducted on ( 45 ) pediatric patients aged 3-12 years , weighting between 10-30 kg , and of American Society of Anesthesiologists (ASA) physical status I and II scheduled for major abdominal surgeries
- Conditions
- Major Abdominal Surgeries
- Being tested
- Intrathecal Morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
Also called morphine sulphate
Intrathecal administration of Morphine in children undergoing major abdominal surgeries
| Study group | Role | What they receive |
|---|---|---|
| morphine 2 μg/kg | Active comparator | Children will receive intrathecal morphine 2 μg/kg in 2 ml volume normal saline. Receives: Drug: Intrathecal Morphine |
| morphine 5 μg/kg | Active comparator | Children will receive intrathecal morphine 5 μg/kg in 2 ml volume normal saline. Receives: Drug: Intrathecal Morphine |
| morphine 10 μg/kg | Active comparator | Children will receive intrathecal morphine 10 μg/kg in 2 ml volume normal saline. Receives: Drug: Intrathecal Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
0- 10 in cm score range will be used to assess pain
Measured: 24 hours postoperative .
Secondary outcomes (1)
rams y sedation score
0-4 score will be used
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 Jan 2017
- Primary completion1 Mar 2017
- Study completion1 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeriesStudies of the same condition, open and under way.
- More trials run by Assiut 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, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Abdel Baky Mohamed, Assiut University
- Investigators
- Sahar A Mohamed, MD, Principal investigator, south egypt cancer instutite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158584
- Sponsor's protocol ID
- 343
- Status last verified
- Jul 2016
- First submitted
- 14 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries, Dose-finding Clinical Study
- ClinicalTrials.gov ID
- NCT03158584
- Acronym / sponsor ID
- 343
- Conditions
- Major Abdominal Surgeries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Jul 2017 (estimated)
- First posted
- 18 May 2017 (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.
safety and efficacy of intrathecal morphine in post operative pain relief in pediatric patients undergoing major abdominal cancer surgeries using different doses of intrathecal morphine (2 μg/kg , 5 μg/kg ,10 μg/kg).
Detailed description
After obtaining approval of the local ethics committee of faculty of medicine, Assiut University , Assiut , Egypt , and parent's written informed consent, This randomized double -blinded prospective study conducted on ( 45 ) pediatric patients aged 3-12 years , weighting between 10-30 kg , and of American Society of Anesthesiologists (ASA) physical status I and II scheduled for major abdominal surgeries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| morphine 2 μg/kg | Active comparator | Drug: Intrathecal MorphineChildren will receive intrathecal morphine 2 μg/kg in 2 ml volume normal saline. |
| morphine 5 μg/kg | Active comparator | Drug: Intrathecal MorphineChildren will receive intrathecal morphine 5 μg/kg in 2 ml volume normal saline. |
| morphine 10 μg/kg | Active comparator | Drug: Intrathecal MorphineChildren will receive intrathecal morphine 10 μg/kg in 2 ml volume normal saline. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- weight between 10-30 kg ,
- American Society of Anesthesiologists (ASA) I - II
- major abdominal surgeries
Key exclusion criteria (4 listed)
- Children with sacral bone abnormalities
- spina bifida
- coagulopathy
- mental delay or retardation
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 |
|---|---|---|
| Intrathecal MorphineAlso: morphine sulphateIntrathecal administration of Morphine in children undergoing major abdominal surgeries | Drug | morphine 10 μg/kg, morphine 2 μg/kg, morphine 5 μg/kg |
Primary outcome
visual analog scale
Time frame: 24 hours postoperative .
0- 10 in cm score range will be used to assess pain
1 secondary outcome
rams y sedation score
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Sahar A Mohamed, MD principal investigator
south egypt cancer instutite
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal Morphine in people with Major Abdominal Surgeries, run by Assiut 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 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 23 May 2017. 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?
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?
visual analog scale (time frame: 24 hours postoperative .). 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 23 May 2017.