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Completed

NCT Number: NCT03885427

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

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.

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Key information

Conditions

Conscious Sedation Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Analgesia Signs and Symptoms

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Zagazig University Hospitsals

Zagazig, 055, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine

Drug

evaluate sedative, and analgesic effects of oral or nebulized ketamine

Other names: ketalar

Primary outcomes

  1. 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:

    • 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.

    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):

    • 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.

    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):

    • Calm.
    • Apprehensive, not smiling, tentative behavior, withdrawn.
    • Crying.
    • Thrashing, crying with movements of the arms, and legs, resisting.

Secondary outcomes

  1. to compare the intensity of pain postoperative.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery: A-Comparative Randomized Double Blind Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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