Procedural Sedation and Analgesia During Bone Marrow Aspiration and BiopsyNCT03647579
Dexmedetomidine Versus Midazolam Added to Ketamine in Pediatric Patients Undergoing Bone Marrow Aspiration and Biopsy
A study testing midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine and Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine in people with Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy, run by Assiut University at 1 site in Egypt.
Trial summary
Group I :The patients will receive midazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv). Group II : The patients will receive Dexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy
- What is being tested?
- midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine and Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2018to 20 Apr 2019
- 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
- All consecutive children with acute lymphoblastic leukemia undergoing bone marrow aspiration and biopsy.
Who cannot join
- previous sensitization or anaphylactic reaction to Dexmedetomidine, ketamine,and midazolam;
- evidence of head injury,
- raised intracranial or intraocular tension;
- use of drugs known to interact with either study agent;
- an American Society of Anesthesiologists (ASA) physical status score greater than 2.
- Also Patients with cardiovascular, respiratory, hepatic diseases and epilepsy will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Single Dose Dexmedetomidine Versus Midazolam on Emergence Agitation and Recovery Profile When Added to Ketamine for Procedural Sedation and Analgesia in Pediatric Patients Undergoing Bone Marrow Aspiration and Biopsy
Group I :The patients will receive midazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv).
Group II : The patients will receive Dexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv).
The objective of this study to evaluate the clinical effects, adverse effects and recovery time of two different sedative agents (midazolam and Dexmedetomidine) combined with ketamine during conscious sedation for child patient with haematological cancer undergoing BMA \&biopsy.
- Being tested
- midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine, Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamineDrug
midazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine
Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamineDrug
Dexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine
| Study group | Role | What they receive |
|---|---|---|
| midazolam plus ketamine | Active comparator | Not described Receives: Drug: midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine |
| dexmedetomidine plus ketamine | Active comparator | Not described Receives: Drug: Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of drug mixture on procedural sedation and analgesia: Ramsay sedation score
to assess efficacy of procedural sedation and analgesia with drug mixture;using Ramsay sedation score.
Ramsay score
- Nervous, agitated, and/or restless.
- Cooperative, orientated, quite patient.
- Only obeying orders.
- Sleeping, hitting the glabella, and responding to high voice suddenly
- Sleeping, hitting the glabella, and responding to high voice slowly
- No response to any of these stimulations Dexemeditomidine and midazolam will be started 2 minutes before procedure through a peripheral venous cannula and continued as maintainance, then ketamine will be administered over 10-20 s aiming to achieve a sedation level of 3 or 4 on Ramsay scale to start the procedure.
Measured: within the time of the procedure of bone marrow aspirate and biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start30 Aug 2018
- Primary completion15 Dec 2018
- Study completion20 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural Sedation and Analgesia During Bone Marrow Aspiration and BiopsyStudies 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, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed H Othman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647579
- Sponsor's protocol ID
- 17100208
- Status last verified
- Oct 2019
- First submitted
- 23 Aug 2018
- Last updated
- 3 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single Dose Dexmedetomidine Versus Midazolam on Emergence Agitation and Recovery Profile When Added to Ketamine for Procedural Sedation and Analgesia in Pediatric Patients Undergoing Bone Marrow Aspiration and Biopsy
- ClinicalTrials.gov ID
- NCT03647579
- Acronym / sponsor ID
- 17100208
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 20 Apr 2019 (actual)
- First posted
- 27 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.
Group I :The patients will receive midazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv).
Group II : The patients will receive Dexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv).
The objective of this study to evaluate the clinical effects, adverse effects and recovery time of two different sedative agents (midazolam and Dexmedetomidine) combined with ketamine during conscious sedation for child patient with haematological cancer undergoing BMA \&biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midazolam plus ketamine | Active comparator | Drug: midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine |
| dexmedetomidine plus ketamine | Active comparator | Drug: Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All consecutive children with acute lymphoblastic leukemia undergoing bone marrow aspiration and biopsy.
Key exclusion criteria (6 listed)
- previous sensitization or anaphylactic reaction to Dexmedetomidine, ketamine,and midazolam;
- evidence of head injury,
- raised intracranial or intraocular tension;
- use of drugs known to interact with either study agent;
- an American Society of Anesthesiologists (ASA) physical status score greater than 2.
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 |
|---|---|---|
| midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketaminemidazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine | Drug | midazolam plus ketamine |
| Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamineDexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine | Drug | dexmedetomidine plus ketamine |
Primary outcome
efficacy of drug mixture on procedural sedation and analgesia: Ramsay sedation score
Time frame: within the time of the procedure of bone marrow aspirate and biopsy
to assess efficacy of procedural sedation and analgesia with drug mixture;using Ramsay sedation score. Ramsay score 1. Nervous, agitated, and/or restless. 2. Cooperative, orientated, quite patient. 3. Only obeying orders. 4. Sleeping, hitting the glabella, and responding to high voice suddenly 5. Sleeping, hitting the glabella, and responding to high voice slowly 6. No response to any of these stimulations Dexemeditomidine and midazolam will be started 2 minutes before procedure through a peripheral venous cannula and continued as maintainance, then ketamine will be administered over 10-20 s aiming to achieve a sedation level of 3 or 4 on Ramsay scale to start the procedure.
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 3 Oct 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine and Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine in people with Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy, 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 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 3 Oct 2019. 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?
efficacy of drug mixture on procedural sedation and analgesia: Ramsay sedation score (time frame: within the time of the procedure of bone marrow aspirate and biopsy). 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 3 Oct 2019.