Cannula Site PainPhase 2/3NCT04704622
Comparison Between Dexmeditomidine, Midazolam and Ketamine as a Sedative to Help Cannula Insertion in Pediatric Patient
A Phase 2/3 study testing Ketamine, Midazolam and Dexmedetomidine in people with Cannula Site Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Background and Objectives: Surgery and hospitalization present a very stressful period for children and their parents. The induction of anesthesia and cannula insertion may be the only bad experience a child can remember during his procedure. Read more about this study
- Who is it for?
- Ages 2 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannula Site Pain
- What is being tested?
- Ketamine, Midazolam and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 15 Feb 2021
- Phase
- Phase 2/3
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child aged between 2-9 years scheduled for minor elective surgical procedures (last 1-2 hours) at pediatric surgery department.
- Patients were ASA I or II.
- within normal range of weight.
- refusing venous cannulation
Who cannot join
- parents' refusal
- with nasal deformity or pathology
- any known case of allergy to the study drugs
- obese patients
- suspected difficult airway or venous cannulation.
- maxillofacial malformations
Show all 11Show fewer
- gastroesophageal reflux
- patients with renal, liver, endocrine or cardiac pathology
- patients with increased intracranial or intraocular pressure
- patients with sleep apnea
- any patient with a preexisting cannula or accepting cannula insertion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Intranasal Midazolam, Dexmedetomidine, Ketamine for Their Sedative Effect and the Ability to Facilitate Venous Cannulation in Pediatric Patients: a Prospective Randomized Study.
Background and Objectives: Surgery and hospitalization present a very stressful period for children and their parents. The induction of anesthesia and cannula insertion may be the only bad experience a child can remember during his procedure. Pediatric intravenous cannulation is technically difficult and moreover may cause psychological problems. Sedative Premedication has a great role in pediatric anesthesia to overcome fear and anxiety and to facilitate easy separation from their parents. Intranasal approach is safe and painless and well tolerated by children in addition to a comparable onset of action with the intravenous approach. Midazolam, dexmedetomidine and ketamine have proved their effectiveness as a sedative premedication. The objective of the current study was to compare the effectiveness of administration of intranasal midazolam, dexmedetomidine and ketamine as sedatives to facilitate and decrease the discomfort of intravenous cannulation before surgery in children undergoing various surgical procedures. Methods: the patients agreed to participate in the research were classified into 3 groups. Dexmedetomidine, Midazolam and Ketamine group; each group received the intranasal drug 30 min before the procedure. Pulse, MAP, oxygen saturation and sedation score (MOAA/S) baseline and every 10 min. Easiness of venipuncture, parental separation and any complication encountered were recorded.
Read the detailed description
Background and Objectives: Surgery and hospitalization present a very stressful period for children and their parents. The induction of anesthesia and cannula insertion may be the only bad experience a child can remember during his procedure. Pediatric intravenous cannulation is technically difficult and moreover may cause psychological problems. Sedative Premedication has a great role in pediatric anesthesia to overcome fear and anxiety and to facilitate easy separation from their parents. Intranasal approach is safe and painless and well tolerated by children in addition to a comparable onset of action with the intravenous approach. Midazolam, dexmedetomidine and ketamine have proved their effectiveness as a sedative premedication. We assumed that intranasal midazolam, dexmedetomidine and ketamine would help anesthetics to carry out venous cannulation easily; in addition to their sedative premedication effect.
The objective of the current study was to compare the effectiveness of administration of intranasal midazolam, dexmedetomidine and ketamine as sedatives to facilitate and decrease the discomfort of intravenous cannulation before surgery in children undergoing various surgical procedures.
Study design: 150 patients agreed to participate in the research after written informed consent. patients were classified into 3 groups. Dexmedetomidine, Midazolam and Ketamine group; each group received the intranasal drug 30 min before the procedure. Pulse, MAP, oxygen saturation and sedation score (MOAA/S) baseline and every 10 min. Easiness of venipuncture, parental separation and any complication encountered were recorded. Group assignment, preparation and administration of drugs will be performed by a junior anesthetist who is neither involved nor interested by any means in the study.
- Conditions
- Cannula Site Pain
- Being tested
- Ketamine, Midazolam, Dexmedetomidine
- Keywords
- dexmedetomidine, ketamine, midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called ket
ketamine intranasal injection,2 mg/kg, once, 30 min preoperative
MidazolamDrug
Also called mid
midazolam intranasal injection,0.2mg/kg, once, 30 min preoperative
DexmedetomidineDrug
Also called dex
dexmedetomidine intranasal injection,1 μg/kg, once, 30 min preoperative
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine group | Active comparator | dexmedetomidine intranasal injection,1 μg/kg, once, 30 min preoperative Receives: Drug: Dexmedetomidine |
| ketamine | Active comparator | ketamine intranasal injection,2 mg/kg, once, 30 min preoperative Receives: Drug: Ketamine |
| midazolam | Active comparator | midazolam intranasal injection,0.2 mg/kg, once, 30 min preoperative Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of Modified Observer Assessment of Alertness and Sedation scale(MOAA/S) at different time intervals
scale measuring level of sedation from 1-6 points. 1 is referring to no sedation and 6 is the maximum sedation. reaching score of 4 is the sedation level needed to insert the cannula.
Measured: measuring the Modified Observer Assessment of Alertness and Sedation scale every 10 minutes preoperative till induction of anesthesia up to 30 minutes
Secondary outcomes (4)
the change in measuring pulse rate/ minutes at different time intervals
measuring pulse rate/ minutes every 10 minutes at baseline till the end of surgery
Measured: the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours
the change in Mean Arterial Pressure at different time intervals
measuring Mean Arterial Pressure every 10 minutes at baseline till the end of surgery
Measured: the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours
the change in oxygen saturation at different time intervals
measuring oxygen saturation every 10 minutes at baseline till the end of surgery
Measured: the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours
the ease of venipuncture score
poor, fair, good, excellent
Measured: done by the anesthetist immediately after the cannula insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start1 Jan 2021
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannula Site PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Gamal Abusinna, Ain Shams University
- Investigators
- Rasha G Abusinna, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704622
- Sponsor's protocol ID
- Rasha Abusinna
- Status last verified
- May 2021
- First submitted
- 4 Jan 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Intranasal Midazolam, Dexmedetomidine, Ketamine for Their Sedative Effect and the Ability to Facilitate Venous Cannulation in Pediatric Patients: a Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT04704622
- Acronym / sponsor ID
- Rasha Abusinna
- Conditions
- Cannula Site Pain
- Keywords
- dexmedetomidine, ketamine, midazolam
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 11 Jan 2021 (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.
Background and Objectives: Surgery and hospitalization present a very stressful period for children and their parents. The induction of anesthesia and cannula insertion may be the only bad experience a child can remember during his procedure. Pediatric intravenous cannulation is technically difficult and moreover may cause psychological problems. Sedative Premedication has a great role in pediatric anesthesia to overcome fear and anxiety and to facilitate easy separation from their parents. Intranasal approach is safe and painless and well tolerated by children in addition to a comparable onset of action with the intravenous approach. Midazolam, dexmedetomidine and ketamine have proved their effectiveness as a sedative premedication. The objective of the current study was to compare the effectiveness of administration of intranasal midazolam, dexmedetomidine and ketamine as sedatives to facilitate and decrease the discomfort of intravenous cannulation before surgery in children undergoing various surgical procedures. Methods: the patients agreed to participate in the research were classified into 3 groups. Dexmedetomidine, Midazolam and Ketamine group; each group received the intranasal drug 30 min before the procedure. Pulse, MAP, oxygen saturation and sedation score (MOAA/S) baseline and every 10 min. Easiness of venipuncture, parental separation and any complication encountered were recorded.
Detailed description
Background and Objectives: Surgery and hospitalization present a very stressful period for children and their parents. The induction of anesthesia and cannula insertion may be the only bad experience a child can remember during his procedure. Pediatric intravenous cannulation is technically difficult and moreover may cause psychological problems. Sedative Premedication has a great role in pediatric anesthesia to overcome fear and anxiety and to facilitate easy separation from their parents. Intranasal approach is safe and painless and well tolerated by children in addition to a comparable onset of action with the intravenous approach. Midazolam, dexmedetomidine and ketamine have proved their effectiveness as a sedative premedication. We assumed that intranasal midazolam, dexmedetomidine and ketamine would help anesthetics to carry out venous cannulation easily; in addition to their sedative premedication effect.
The objective of the current study was to compare the effectiveness of administration of intranasal midazolam, dexmedetomidine and ketamine as sedatives to facilitate and decrease the discomfort of intravenous cannulation before surgery in children undergoing various surgical procedures.
Study design: 150 patients agreed to participate in the research after written informed consent. patients were classified into 3 groups. Dexmedetomidine, Midazolam and Ketamine group; each group received the intranasal drug 30 min before the procedure. Pulse, MAP, oxygen saturation and sedation score (MOAA/S) baseline and every 10 min. Easiness of venipuncture, parental separation and any complication encountered were recorded. Group assignment, preparation and administration of drugs will be performed by a junior anesthetist who is neither involved nor interested by any means in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine group | Active comparator | Drug: Dexmedetomidinedexmedetomidine intranasal injection,1 μg/kg, once, 30 min preoperative |
| ketamine | Active comparator | Drug: Ketamineketamine intranasal injection,2 mg/kg, once, 30 min preoperative |
| midazolam | Active comparator | Drug: Midazolammidazolam intranasal injection,0.2 mg/kg, once, 30 min preoperative |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- child aged between 2-9 years scheduled for minor elective surgical procedures (last 1-2 hours) at pediatric surgery department.
- Patients were ASA I or II.
- within normal range of weight.
- refusing venous cannulation
Key exclusion criteria (11 listed)
- parents' refusal
- with nasal deformity or pathology
- any known case of allergy to the study drugs
- obese patients
- suspected difficult airway or venous cannulation.
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 |
|---|---|---|
| KetamineAlso: ketketamine intranasal injection,2 mg/kg, once, 30 min preoperative | Drug | ketamine |
| MidazolamAlso: midmidazolam intranasal injection,0.2mg/kg, once, 30 min preoperative | Drug | midazolam |
| DexmedetomidineAlso: dexdexmedetomidine intranasal injection,1 μg/kg, once, 30 min preoperative | Drug | dexmedetomidine group |
Primary outcome
the change of Modified Observer Assessment of Alertness and Sedation scale(MOAA/S) at different time intervals
Time frame: measuring the Modified Observer Assessment of Alertness and Sedation scale every 10 minutes preoperative till induction of anesthesia up to 30 minutes
scale measuring level of sedation from 1-6 points. 1 is referring to no sedation and 6 is the maximum sedation. reaching score of 4 is the sedation level needed to insert the cannula.
4 secondary outcomes
the change in measuring pulse rate/ minutes at different time intervals
Time frame: the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours
the change in Mean Arterial Pressure at different time intervals
Time frame: the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours
the change in oxygen saturation at different time intervals
Time frame: the recorded score at baseline and every 10 minutes preoperative till induction of anesthesia and intraoperative in a surgery 1-2 hours
the ease of venipuncture score
Time frame: done by the anesthetist immediately after the cannula insertion
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 28 May 2021.
- Individual participant dataSharing planned: No
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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.
Rasha G Abusinna, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine, Midazolam and Dexmedetomidine in people with Cannula Site Pain, run by Ain Shams 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 4 inclusion and 11 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 28 May 2021. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
the change of Modified Observer Assessment of Alertness and Sedation scale(MOAA/S) at different time intervals (time frame: measuring the Modified Observer Assessment of Alertness and Sedation scale every 10 minutes preoperative till induction of anesthesia up to 30 minutes). 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 28 May 2021.