Hematological Malignancy (Leukemia- Lymphoma)Phase 4NCT03649334
Ketamine-ketorolac Versus Fentanyl- Ketorolac I.M in Children During Bone Marrow Biopsy
A Phase 4 study testing ketamine-ketorolac and fentanyl- ketorolac in people with Hematological Malignancy (Leukemia- Lymphoma), run by Mansoura University at 1 site in Egypt.
Trial summary
investigators aim to compare between anaesthetic regimens that included dual-agent (fentanyl and ketorolac) or (ketamine and ketorolac) analgesic therapy Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Hematological Malignancy (Leukemia- Lymphoma)
- What is being tested?
- ketamine-ketorolac and fentanyl- ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Aug 2018to 15 Oct 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status II
Who cannot join
- Any known allergy to the studied drugs.
- congenital heart disease
- Any cardiac problems.
- Use of psychotropic medication
- mental retardation
- any organ dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Intra-muscular Ketamine-ketorolac Versus Fentanyl- Ketorolac for Children Undergoing Bone Marrow Biopsy and Aspiration
investigators aim to compare between anaesthetic regimens that included dual-agent (fentanyl and ketorolac) or (ketamine and ketorolac) analgesic therapy
Read the detailed description
regarding patient registry; a prior G power analysis was done. Based on the assumption that the pain score in intramuscular ketamine group will be similar to similar to those in previously published data; forty children would be required per group to detect a difference of 30% in CHEOPS pain scores with a power of 90% (α =0.05, β =0.1)
- Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences), program version 22. Distribution of data will be first tested by the Shapiro test. Data will be presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, the unpaired t-test will be used to compare the mean values of both groups. For pain and emergence behaviour scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.
- Being tested
- ketamine-ketorolac, fentanyl- ketorolac
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamine-ketorolacDrug
The patient will receive ketamine 0.5mg.kg-1 + ketorolac 1mk.kg-1 in 2 ml syringe intramuscularly.
fentanyl- ketorolacDrug
The patient will receive fentanyl 1.5ug.kg-1 + ketorolac 1 mg.kg-1 in 2ml syringe intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| ketamine-ketorolac | Other | The patient will receive ketamine in conjunction with intramuscular ketorolac Receives: Drug: ketamine-ketorolac |
| fentanyl- ketorolac | Other | The patient will receive fentanyl in conjunction with intramuscular ketorolac Receives: Drug: fentanyl- ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be assessed by the CHEOP scale (Children's Hospital of Eastern Ontario Pain Scale)The scale includes six entries with an appropriate point evaluation focused on the character of crying (1-3 points), facial expressions (0-2 points), verbal reaction (0-2 points), position of the body (1-2 points), touch (1-2 points), and position of the legs (1-2 points). Minimum score is 4 (no pain) and maximum is 13 (maximum pain). Grades are summed together. CHEOPS has a minimum possible score of 4 points (no pain) to a maximum of 13 points (the worst pain).
When the postoperative pain score exceeded four, rescue analgesia was given with a 20mg/kg paracetamol suppository.
Measured: for 60 minutes later admission to the post-anaesthesia care unit
Secondary outcomes (7)
Heart rate
Heart rate (beat/minute) using ECG monitoring
Measured: at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes
systolic blood pressure
systolic blood pressure (mmHg) using sphygmomanometer cuff
Measured: at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes
The time to the first demand for rescue analgesic
The time to the first demand for rescue analgesic (minutes or hours)
Measured: during first 24 hours postoperative
total number of children who required postoperative pain medication
Measured: for 24 hours after surgery
emergence behavior
-emergence behavior will be measured using Aono's four point scale : (1) Asleep; (2) Awake but calm; (3) Agitated but consolable; and (4) Severely agitated and difficult to console and the highest-recorded value was recorded during the Post anesthesia care unit stay. Lowest score is 1 and highest score is 4 The higher score indicates more emergence agitation. For purposes of analysis, grades 1 and 2 in the scale of behavior were considered no agitation and grades 3 and 4 were considered the presence of agitation.
Measured: every 5 minutes during first 30 minutes of recovery
nausea, vomiting
Number of attacks of nausea and/or vomiting
Measured: during first 24 hours postoperative
respiratory difficulty
signs of respiratory difficulty:
- Breathing rate. An increase in the number of breaths per minute (>35 breath/minute)
- Increased heart rate.
- Color changes. A bluish color seen around the mouth, on the inside of the lips, or on the fingernails
- Grunting. A grunting sound can be heard each time the person exhales.
- Nose flaring. The openings of the nose spreading open while breathing
- Retractions. The chest appears to sink in just below the neck and/or under the breastbone with each breath-
- Sweating. There may be increased sweat on the head, but the skin does not feel warm to
Measured: during first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start26 Aug 2018
- Primary completion1 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological Malignancy (Leukemia- Lymphoma)Studies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enas A Abd el Motlb, MD, Study chair, Assisitant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649334
- Sponsor's protocol ID
- R/18.06.213
- Status last verified
- Sep 2020
- First submitted
- 18 Aug 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Intra-muscular Ketamine-ketorolac Versus Fentanyl- Ketorolac for Children Undergoing Bone Marrow Biopsy and Aspiration
- ClinicalTrials.gov ID
- NCT03649334
- Acronym / sponsor ID
- R/18.06.213
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 26 Aug 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 28 Aug 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.
investigators aim to compare between anaesthetic regimens that included dual-agent (fentanyl and ketorolac) or (ketamine and ketorolac) analgesic therapy
Detailed description
regarding patient registry; a prior G power analysis was done. Based on the assumption that the pain score in intramuscular ketamine group will be similar to similar to those in previously published data; forty children would be required per group to detect a difference of 30% in CHEOPS pain scores with a power of 90% (α =0.05, β =0.1)
- Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences), program version 22. Distribution of data will be first tested by the Shapiro test. Data will be presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, the unpaired t-test will be used to compare the mean values of both groups. For pain and emergence behaviour scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine-ketorolac | Other | Drug: ketamine-ketorolacThe patient will receive ketamine in conjunction with intramuscular ketorolac |
| fentanyl- ketorolac | Other | Drug: fentanyl- ketorolacThe patient will receive fentanyl in conjunction with intramuscular ketorolac |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status II
Key exclusion criteria (6 listed)
- Any known allergy to the studied drugs.
- congenital heart disease
- Any cardiac problems.
- Use of psychotropic medication
- mental 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 |
|---|---|---|
| ketamine-ketorolacThe patient will receive ketamine 0.5mg.kg-1 + ketorolac 1mk.kg-1 in 2 ml syringe intramuscularly. | Drug | ketamine-ketorolac |
| fentanyl- ketorolacThe patient will receive fentanyl 1.5ug.kg-1 + ketorolac 1 mg.kg-1 in 2ml syringe intramuscularly | Drug | fentanyl- ketorolac |
Primary outcome
Postoperative pain
Time frame: for 60 minutes later admission to the post-anaesthesia care unit
Postoperative pain will be assessed by the CHEOP scale (Children's Hospital of Eastern Ontario Pain Scale)The scale includes six entries with an appropriate point evaluation focused on the character of crying (1-3 points), facial expressions (0-2 points), verbal reaction (0-2 points), position of the body (1-2 points), touch (1-2 points), and position of the legs (1-2 points). Minimum score is 4 (no pain) and maximum is 13 (maximum pain). Grades are summed together. CHEOPS has a minimum possible score of 4 points (no pain) to a maximum of 13 points (the worst pain). When the postoperative pain score exceeded four, rescue analgesia was given with a 20mg/kg paracetamol suppository.
7 secondary outcomes
Heart rate
Time frame: at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes
systolic blood pressure
Time frame: at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes
The time to the first demand for rescue analgesic
Time frame: during first 24 hours postoperative
total number of children who required postoperative pain medication
Time frame: for 24 hours after surgery
emergence behavior
Time frame: every 5 minutes during first 30 minutes of recovery
nausea, vomiting
Time frame: during first 24 hours postoperative
respiratory difficulty
Time frame: during first 24 hours postoperative
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 9 Sep 2020.
- Individual participant dataSharing planned: 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.
Enas A Abd el Motlb, MD study chair
Assisitant Professor
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 ketamine-ketorolac and fentanyl- ketorolac in people with Hematological Malignancy (Leukemia- Lymphoma), run by Mansoura 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 1 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 9 Sep 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.
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?
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?
Postoperative pain (time frame: for 60 minutes later admission to the post-anaesthesia care unit). 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 Sep 2020.