Conscious SedationEarly Phase 1NCT03885427
Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery.
A Early Phase 1 study testing Ketamine in people with Conscious Sedation and Postoperative Analgesia, run by Zagazig University at 1 site in Egypt.
Trial summary
the primary objective of this study is to investigate the sedative, and analgesic effects of oral, or nebulized ketamine as premedication drugs, and providing postoperative analgesia for the preschoolers and decrease their need for systemic analgesia.The secondary objective is to compare each sedation technique after… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Conscious Sedation, Postoperative Analgesia
- What is being tested?
- Ketamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Mar 2019to 1 Jun 2019
- Phase
- Early Phase 1
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents acceptance.
- Age (3-6) years old.
- American Society of Anesthesiologist physical status (ASA) I / II
- Elective surgery of approximately half to one hour duration under general anesthesia.
- Child With Body Mass Index (BMI) (15-18kg/m²)
Who cannot join
- Parents refusal.
- Altered mental status, and epilepsy.
- History of allergy to ketamine.
- Recent respiratory tract infection.
- Sever dysfunction of the central nervous system.
- Increased intracranial pressure, and increased intra-ocular pressure.
- Cardiac dysrhythmia ,and/or congenital heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery: A-Comparative Randomized Double Blind Study
the primary objective of this study is to investigate the sedative, and analgesic effects of oral, or nebulized ketamine as premedication drugs, and providing postoperative analgesia for the preschoolers and decrease their need for systemic analgesia.The secondary objective is to compare each sedation technique after oral, or nebulized ketamine for safety ,and procedural outcomes.
Read the detailed description
Preoperative communication, premedication interventions, and being accompanied by parents are useful methods in decreasing preoperative separation anxiety , postoperative psychological trauma, and ensuring smooth induction for preschoolers undergoing elective surgery.
Procedural sedation, and analgesia was defined by O'Donnell as a drug induced state of decreasing awareness, pain, and memory that allowing patient continue his ,or her own protective reflexes, and moving purposefully( O' Donnell etal, 2003).
Ketamine is an anesthetic drug having sedative, and analgesic properties with different routes of administration in children (IV, intramuscular, subcutaneous, oral, rectal, sublingual, intranasal, and nebulized) .
Ketamine produces its analgesic properties in acut pain management from reversible antagonizing the N-methyl-D-aspartate (NMDA)receptors , reducing levels of many proinflammatory mediators in the acute phase, and acting on other non-NMDA pathways that playing important roles in pain, and mood regulation, like its effect on µ-opioid receptors, nicotinic, muscarinic cholinergic, ɣ-aminobutyric acid receptors, activation of high -affinity D2 dopamine receptors, and L-type voltage-gated calcium channels.
The oral route is the most popular than other routes ,as it's safe, efficient, acceptable, and familiar for pediatric patients..
Oral ketamine often requires higher, and frequent doses as it's bioavailability is lower (17-24%) compared to IV (100%),Intramuscular (93%), sublingual/transbuccal(30%), intranasal(25-50%),and inhaler (70%) due to extensive first pass metabolism in liver, and intestine.
Ketamine inhalation is safe, rapid absorption, and affordable route of administration.
- Conditions
- Conscious Sedation, Postoperative Analgesia
- Being tested
- Ketamine
- Keywords
- sedation, ketamine, analgesia, pre-schoolers
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called ketalar
evaluate sedative, and analgesic effects of oral or nebulized ketamine
| Study group | Role | What they receive |
|---|---|---|
| oral ketamine | Experimental | evaluate sedative,and analgesic effects Receives: Drug: Ketamine |
| nebulized ketamine | Active comparator | evaluate sedative, and analgesic effects Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate sedative effects of oral, or nebulized ketamine in preschoolers undergoing elective surgery
- To assess onset time of sedation by sedation scale (SS-5) score.
The sedation scale:
- Rarely awake, needs shaking, or shouting to wake up.
- Asleep, eyes closed, wake up when called softly,or lightly touched.
- Sleepy, but eyes open spontaneously.
- Awake.
- Agitated.
Measured: 30 minutes.
compare each sedation technique for the time of separation state.
The separation state will be assessed and designated as satisfactory separation if the Emotional State Scale (ESS-4) score will be no more than two points.
The Emotional State Scale (ESS-4):
- Calm.
- Apprehensive, not smiling, tentative behavior, withdrawn.
- Crying.
- Thrashing, crying with movements of the arms, and legs, resisting.
Measured: at 30 minutes after drug intake
compare the sedation technique for successful venous cannulation.
Successful venous cannulation is defined as an Emotional State Scale (ESS-4≤ 2).
The Emotional State Scale (ESS-4):
- Calm.
- Apprehensive, not smiling, tentative behavior, withdrawn.
- Crying.
- Thrashing, crying with movements of the arms, and legs, resisting.
Measured: at time of attempted cannulation, regardless of whether the vein is actually cannulated on the first attempt.
Secondary outcomes (1)
to compare the intensity of pain postoperative.
the intensity of pain will be assessed using modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS).
Score 1 2 3 Cry No cry Crying, moaning Scream Facial Smiling Composed Grimace Verbal Positive None, or other complaints Pain complaint Torso Neutral Shifting, tense, upright Restrained Leg Neutral kicks, squirm, drawn up Restrained Touch No touching Reach, touch, grab Restrained CHEOPS pain score=SUM(0)(points for all 6 parameters). Interpretation : minimum score:6, maximum score:18.
Measured: immediately after recovery, and every half hour for four hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start27 Mar 2019
- Primary completion15 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- this will be a double blind study, and utilize a convenience sample of pre-schoolers. 31 children recruited in In oral ketamine arm, and 31 children in nebulized ketamine arm
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alshaimaa Abdel Fattah Kamel, Zagazig University
- Investigators
- Alshaimaa Kamel, M.D, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885427
- Sponsor's protocol ID
- 5296
- Status last verified
- Jun 2019
- First submitted
- 14 Mar 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery: A-Comparative Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT03885427
- Acronym / sponsor ID
- 5296
- Conditions
- Conscious Sedation, Postoperative Analgesia
- Keywords
- sedation, ketamine, analgesia, pre-schoolers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 21 Mar 2019 (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 primary objective of this study is to investigate the sedative, and analgesic effects of oral, or nebulized ketamine as premedication drugs, and providing postoperative analgesia for the preschoolers and decrease their need for systemic analgesia.The secondary objective is to compare each sedation technique after oral, or nebulized ketamine for safety ,and procedural outcomes.
Detailed description
Preoperative communication, premedication interventions, and being accompanied by parents are useful methods in decreasing preoperative separation anxiety , postoperative psychological trauma, and ensuring smooth induction for preschoolers undergoing elective surgery.
Procedural sedation, and analgesia was defined by O'Donnell as a drug induced state of decreasing awareness, pain, and memory that allowing patient continue his ,or her own protective reflexes, and moving purposefully( O' Donnell etal, 2003).
Ketamine is an anesthetic drug having sedative, and analgesic properties with different routes of administration in children (IV, intramuscular, subcutaneous, oral, rectal, sublingual, intranasal, and nebulized) .
Ketamine produces its analgesic properties in acut pain management from reversible antagonizing the N-methyl-D-aspartate (NMDA)receptors , reducing levels of many proinflammatory mediators in the acute phase, and acting on other non-NMDA pathways that playing important roles in pain, and mood regulation, like its effect on µ-opioid receptors, nicotinic, muscarinic cholinergic, ɣ-aminobutyric acid receptors, activation of high -affinity D2 dopamine receptors, and L-type voltage-gated calcium channels.
The oral route is the most popular than other routes ,as it's safe, efficient, acceptable, and familiar for pediatric patients..
Oral ketamine often requires higher, and frequent doses as it's bioavailability is lower (17-24%) compared to IV (100%),Intramuscular (93%), sublingual/transbuccal(30%), intranasal(25-50%),and inhaler (70%) due to extensive first pass metabolism in liver, and intestine.
Ketamine inhalation is safe, rapid absorption, and affordable route of administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- this will be a double blind study, and utilize a convenience sample of pre-schoolers. 31 children recruited in In oral ketamine arm, and 31 children in nebulized ketamine arm
| Arm | Type | Receives |
|---|---|---|
| oral ketamine | Experimental | Drug: Ketamineevaluate sedative,and analgesic effects |
| nebulized ketamine | Active comparator | Drug: Ketamineevaluate sedative, and analgesic effects |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parents acceptance.
- Age (3-6) years old.
- American Society of Anesthesiologist physical status (ASA) I / II
- Elective surgery of approximately half to one hour duration under general anesthesia.
- Child With Body Mass Index (BMI) (15-18kg/m²)
Key exclusion criteria (7 listed)
- Parents refusal.
- Altered mental status, and epilepsy.
- History of allergy to ketamine.
- Recent respiratory tract infection.
- Sever dysfunction of the central nervous system.
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: ketalarevaluate sedative, and analgesic effects of oral or nebulized ketamine | Drug | nebulized ketamine, oral ketamine |
Primary outcome
evaluate sedative effects of oral, or nebulized ketamine in preschoolers undergoing elective surgery
Time frame: 30 minutes.
• To assess onset time of sedation by sedation scale (SS-5) score. The sedation scale: 1. Rarely awake, needs shaking, or shouting to wake up. 2. Asleep, eyes closed, wake up when called softly,or lightly touched. 3. Sleepy, but eyes open spontaneously. 4. Awake. 5. Agitated.
compare each sedation technique for the time of separation state.
Time frame: at 30 minutes after drug intake
The separation state will be assessed and designated as satisfactory separation if the Emotional State Scale (ESS-4) score will be no more than two points. The Emotional State Scale (ESS-4): 1. Calm. 2. Apprehensive, not smiling, tentative behavior, withdrawn. 3. Crying. 4. Thrashing, crying with movements of the arms, and legs, resisting.
compare the sedation technique for successful venous cannulation.
Time frame: at time of attempted cannulation, regardless of whether the vein is actually cannulated on the first attempt.
Successful venous cannulation is defined as an Emotional State Scale (ESS-4≤ 2). The Emotional State Scale (ESS-4): 1. Calm. 2. Apprehensive, not smiling, tentative behavior, withdrawn. 3. Crying. 4. Thrashing, crying with movements of the arms, and legs, resisting.
1 secondary outcome
to compare the intensity of pain postoperative.
Time frame: immediately after recovery, and every half hour for four 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 19 Jun 2019.
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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.
Alshaimaa Kamel, M.D principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketamine in people with Conscious Sedation and Postoperative Analgesia, run by Zagazig 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 5 inclusion and 7 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 19 Jun 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
evaluate sedative effects of oral, or nebulized ketamine in preschoolers undergoing elective surgery (time frame: 30 minutes.). The study lists 3 primary outcomes in all. 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 19 Jun 2019.