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Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery.

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT03885427
Collaborator
(none)
62
Enrollment
1
Location
2
Arms
2.2
Actual Duration (Months)
28.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 armthis 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 (Participant, Outcomes Assessor)
Masking Description:
The investigator will prepare the drug, and the out come assessor(the anesthesiologist not sharing in the study) will assess the primary, and secondary outcomes
Primary Purpose:
Treatment
Official Title:
Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery: A-Comparative Randomized Double Blind Study
Actual Study Start Date :
Mar 27, 2019
Actual Primary Completion Date :
May 15, 2019
Actual Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: oral ketamine

evaluate sedative,and analgesic effects

Drug: Ketamine
evaluate sedative, and analgesic effects of oral or nebulized ketamine
Other Names:
  • ketalar

    		•
    Active Comparator: nebulized ketamine

    evaluate sedative, and analgesic effects

    Drug: Ketamine
    evaluate sedative, and analgesic effects of oral or nebulized ketamine
    Other Names:
  • ketalar

    		•

    Outcome Measures

    Primary Outcome Measures

    1. evaluate sedative effects of oral, or nebulized ketamine in preschoolers undergoing elective surgery [30 minutes.]

      • 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.

    2. compare each sedation technique for the time of separation state. [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): Calm. Apprehensive, not smiling, tentative behavior, withdrawn. Crying. Thrashing, crying with movements of the arms, and legs, resisting.

    3. compare the sedation technique for successful venous cannulation. [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): Calm. Apprehensive, not smiling, tentative behavior, withdrawn. Crying. Thrashing, crying with movements of the arms, and legs, resisting.

    Secondary Outcome Measures

    1. to compare the intensity of pain postoperative. [immediately after recovery, and every half hour for four hours 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zagazig University Hospitsals Zagazig Egypt 055

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    • Principal Investigator: Alshaimaa Kamel, M.D, Zagazig University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alshaimaa Abdel Fattah Kamel, Principal investigator, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT03885427
    Other Study ID Numbers:
    • 5296
    First Posted:
    Mar 21, 2019
    Last Update Posted:
    Jun 19, 2019
    Last Verified:
    Jun 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Alshaimaa Abdel Fattah Kamel, Principal investigator, Zagazig University
    sedation
    ketamine
    analgesia
    pre-schoolers
    Additional relevant MeSH terms:
    Ketamine

    Study Results

    No Results Posted as of Jun 19, 2019