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

• ClinicalTrials.gov Identifier: NCT03885427
• Recruitment Status: Completed
• First Posted: March 21, 2019
• Last Update Posted: June 19, 2019
• Sponsor: Zagazig University
• Information provided by (Responsible Party): Alshaimaa Abdel Fattah Kamel, Zagazig University

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
Conscious Sedation; Postoperative Analgesia	Drug: Ketamine	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 (Clinical Trial)
• 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 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: March 27, 2019
• Actual Primary Completion Date: May 15, 2019
• Actual Study Completion Date: June 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 Name: ketalar
Active Comparator: nebulized ketamine; evaluate sedative, and analgesic effects	Drug: Ketamine; evaluate sedative, and analgesic effects of oral or nebulized ketamine; Other Name: ketalar

Outcome Measures

Primary Outcome Measures :

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:

   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.
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):

   1. Calm.
   2. Apprehensive, not smiling, tentative behavior, withdrawn.
   3. Crying.
   4. 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):

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 Apprehensive, not smiling, tentative behavior, withdrawn.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

Secondary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Egypt

Zagazig University Hospitsals

Zagazig, Egypt, 055

Sponsors and Collaborators

Zagazig University

Investigators

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

More Information

• Responsible Party: Alshaimaa Abdel Fattah Kamel, Principal investigator, Zagazig University
• ClinicalTrials.gov Identifier: NCT03885427
• Other Study ID Numbers: 5296
• First Posted: March 21, 2019
• Last Update Posted: June 19, 2019
• Last Verified: June 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, Zagazig University:

sedation; ketamine; analgesia; pre-schoolers

Additional relevant MeSH terms:

Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action