Protocol summary
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Study aim
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Assessing the efficacy and safety of intranasal midazolam alone versus midazolam/ketamine combination for preoperative sedation prior to ophthalmic procedures in preschool children.
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Design
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Parallel group randomized controlled clinical trial with 1:1 allocation ratio.
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Settings and conduct
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Research Institute of Ophthalmology, Giza, Egypt.
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Participants/Inclusion and exclusion criteria
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We will include children (male or female) aged from 3 to 7 years old, ASA I or II. We will exclude children with anticipated difficult airways [such as facial deformity, cervical spine injury, or some syndromes (e.g. Pierre robin syndrome, Apert syndrome, and Teacher Collins syndrome], increased risk of aspiration [as in anatomical abnormalities, such as cleft palate and problems in the esophagus, neuromuscular diseases, and cerebral palsy], central or obstructive sleep apnea, or previous allergy to the used drugs.
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Intervention groups
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The first group will be given midazolam intranasally in a dose of 0.5 mg/kg and the second group will be given a combination of intranasal midazolam (0.25 mg/kg) and ketamine (1 mg/kg). The drugs will be administered 15 minutes prior to induction of anesthesia.
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Main outcome variables
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The primary outcome variables include preoperative level of sedation, postoperative agitation, and easiness of separation. The secondary outcomes include intraoperative oxygen saturation and pulse rate as well as postoperative nausea and vomiting
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General information
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Reason for update
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Finished recruitment and end of the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201220049777N1
Registration date:
2020-12-31, 1399/10/11
Registration timing:
prospective
Last update:
2021-02-18, 1399/11/30
Update count:
1
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Registration date
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2020-12-31, 1399/10/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-01-15, 1399/10/26
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Expected recruitment end date
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2021-04-15, 1400/01/26
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Actual recruitment start date
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2021-01-15, 1399/10/26
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Actual recruitment end date
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2021-02-08, 1399/11/20
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Trial completion date
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2021-02-08, 1399/11/20
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Scientific title
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Intranasal midazolam alone versus midazolam/ketamine combination for preoperative sedation in pediatric patients undergoing ophthalmic procedures: A randomized controlled trial
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Public title
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Intranasal midazolam/ketamine combination for preoperative sedation in pediatrics
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Children (male or female) aged from 3 to 7 years old
ASA I or II
Children with disability or special needs such as autism and Down syndrome
Children who underwent multiple operative procedures
Children with history of stormy anesthetic induction or emergence
Exclusion criteria:
Anticipated difficult airways, such as facial deformity, cervical spine injury, or some syndromes (e.g. Pierre robin syndrome, Apert syndrome, and Teacher Collins syndrome).
Increased risk of aspiration as in anatomical abnormalities, such as cleft palate and problems in the esophagus, neuromuscular diseases, and cerebral palsy.
Central or obstructive sleep apnea.
Previous allergy or adverse reaction to the used drugs.
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Age
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From 3 years old to 7 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
46
Actual sample size reached:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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We will use the sequentially numbered, opaque sealed envelopes method. We will use envelopes that are impermeable to intense light, and the allocation sequence will be concealed from the physicians enrolling and assessing participants. To prevent subversion of the allocation sequence, the name and hospital admission number of the participant will be written on the envelope. Carbon paper will transfer the information onto the allocation card inside the envelope. Corresponding envelopes will be opened only after the enrolled participants complete all baseline assessments and it is time to allocate the intervention.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Only participants will be blinded to the type of intervention.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-11-08, 1399/08/18
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Ethics committee reference number
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8-11-2020
Health conditions studied
1
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Description of health condition studied
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Preoperative sedation in pediatric patients undergoing ophthalmic procedures.
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Preoperative level of sedation
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Timepoint
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10 minutes after sedation is given
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Method of measurement
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6-Point Pediatric Sedation State Scale
2
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Description
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Postoperative agitation
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Timepoint
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at the time of patient recovery
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Method of measurement
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Emergence Agitation Scale
3
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Description
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Easiness of separation
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Timepoint
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at the time of separation
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Method of measurement
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Separation and Induction Score
Secondary outcomes
1
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Description
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Oxygen saturation
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Timepoint
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every 5 minutes intraoperatively
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Method of measurement
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pulse oximetry
2
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Description
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Pulse rate
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Timepoint
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every 5 minutes intraoperatively
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Method of measurement
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manually
3
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Description
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Postoperative nausea and vomiting
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Timepoint
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30 minutes after recovery
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Method of measurement
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clinical evaluation
Intervention groups
1
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Description
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Intervention group 1: The patients will be given midazolam intranasally in a dose of 0.5 mg/kg. The drug will be administered 15 minutes prior to induction of anesthesia.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: The patients will be given a combination of intranasal midazolam (0.25 mg/kg) and ketamine (1 mg/kg). The drugs will be administered 15 minutes prior to induction of anesthesia.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Self-funded
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Intranasal midazolam and ketamine for preoperative sedation IPD set (all collected deidentified IPD).
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When the data will become available and for how long
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Beginning 6 months and ending 24 months following article publication
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To whom data/document is available
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Researchers from academic institutions whose proposal for the use of data has been approved by an independent review committee identified for this purpose.
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Under which criteria data/document could be used
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For IPD meta-analysis.
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From where data/document is obtainable
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From the PI.
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What processes are involved for a request to access data/document
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A proposal for the use of data to be submitted to the PI, then evaluated by an independent review committee identified for this purpose.
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Comments
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