• 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.
Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery.
Brief 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 oral, or nebulized ketamine for safety ,and procedural outcomes.
Intervention / Treatment
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
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Ketamine (DRUG)evaluate sedative, and analgesic effects of oral or nebulized ketamine
Condition or Disease
- Conscious Sedation
- Postoperative Analgesia
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 3 Years to 6 Years |
| Enrollment: | 62 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingThe investigator will prepare the drug, and the out come assessor(the anesthesiologist not sharing in the study) will assess the primary, and secondary outcomes DOUBLE:
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Clinical Trial Dates
| Start date: | Mar 27, 2019 | ACTUAL |
|---|---|---|
| Primary Completion: | May 15, 2019 | ACTUAL |
| Completion Date: | Jun 01, 2019 | ACTUAL |
| Study First Posted: | Mar 21, 2019 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jun 18, 2019 |
Sponsors / Collaborators
Lead Sponsor:
Zagazig University
Responsible Party:
N/A
Location
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.
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.
Participant Groups
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evaluate sedative,and analgesic effects
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evaluate sedative, and analgesic effects
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 3 |
| Maximum Age: | 6 |
| Age Groups: | Child |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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.
* 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)
Exclusion Criteria:
* 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.
Primary Outcomes
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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.
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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.
Secondary Outcomes
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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.
More Details
| NCT Number: | NCT03885427 |
|---|---|
| Other IDs: | 5296 |
| Study URL: | https://clinicaltrials.gov/study/NCT03885427 |
Last updated: Sep 29, 2023