Intranasal Ketamine and Midazolam Mixture for Procedural Sedation in Children With Mental Disabilities:

NCT03860831 | Unknown Phase 1 DMC

• 1 other identifier: R 57/2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Ketamine and Midazolam are well known sedative drugs that can be given through different routes such as intravenous, intramuscular, oral, rectal and intranasal route. Anesthetic staff usually prefer intravenous route but sometimes inserting venous access is difficult in uncooperative mentally disabled children. Intranasal ketamine+Midazolam can be a needless effective alternative in these vulnerable patients

Conditions

Procedural Sedation

Keywords

nasal; sedation; developmental delay

Outcome Measures

Primary Outcomes (1)

• change in sedation level after intranasal or intramuscular ketamine midazolam mixture administration.

  sedation level measured by Pediatric Sedation State Scale (PSSS): State 5: Movement impedes procedure and requires forceful immobilization State 4: Movement requires gentle immobilization for positioning State 3: Facial expression of pain or anxiety State 2: Quiet, not moving, no frown, no verbalization of complaint (ideal state) State 1: Deeply asleep with normal vital signs, but requires airway intervention or assistance (e.g., central or obstructive apnea) State 0: Deeply asleep with abnormal physiologic parameters that require acute intervention (e.g., O2 saturation \<90%, hypotension, bradycardia) highest score is 0 and least score is 5

  every 10 minutes through the study till one hour after administration

Secondary Outcomes (1)

• parents satisfaction

  two hours after administration

Study Arms (2)

intranasal (IN)

EXPERIMENTAL

Group IN will receive nasal ketamine+midazolam mixture by mucosal atomisation device: midazolam (0.2 mg/kg) +ketamine (5mg/kg). the calculated dose will be equally divided into the two nostrils by the parents

Drug: Ketamine + midazolam

intramuscular (IM)

ACTIVE COMPARATOR

Group IM will receive intramuscular administration of liquid ketamine +midazolam mixture:midazolam (0.2 mg/kg) +ketamine (5mg/kg) in the gluteal region. Mild to moderate restraint was done with the help of the parents during drug administration.

Drug: Ketamine + midazolam

Interventions

Ketamine + midazolam DRUG

Group IN received intranasal midazolam (0.2 mg/kg) +ketamine (5mg/kg). Group IM received intramuscular midazolam (0.2 mg/kg) +ketamine (5mg/kg) in the gluteal region.

Also known as: ketalar +dormicum

intramuscular (IM); intranasal (IN)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Mentally affected children (autism,down syndrome and cerebral palsy)
• children who are scheduled for Short procedures (30 minutes or less) under sedation

You may not qualify if:

• parents refusal.
• child cooperation and acceptance of venipuncture or cannula in situ.
• children with known allergy to ketamine or midazolam.
• liver or renal organ dysfunction.
• suspected difficult cannulation.
• congenital heart disease.
• active pulmonary infection or asthma.
• increased intracranial tension or intraocular pressure.
• severe trauma0
• significant nasal discharge or obstruction.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Sanaa Farag Mahmoud

Cairo, New Cairo, 11835, Egypt

RECRUITING

Ainshams hospitals

Cairo, 11591, Egypt

NOT YET RECRUITING

Related Publications (5)

• Malamed SF. Sedation: A Guide to Patient Management. New York, NY: CV: Mosby-Year Book Inc; 1995. 3rd ed.

  BACKGROUND

• Lee-Kim SJ, Fadavi S, Punwani I, Koerber A. Nasal versus oral midazolam sedation for pediatric dental patients. J Dent Child (Chic). 2004 May-Aug;71(2):126-30.

  PMID: 15587094 BACKGROUND

• Ochs-Ross R,et al. Efficacy and safety of intranasal esketamine plus an oral antidepressant in eldely patients with treatment-resistant depression.Poster PS066 presented at CINP 2018,16-19 june, Vienna, Austria.

  BACKGROUND

• Dallimore D, Herd DW, Short T, Anderson BJ. Dosing ketamine for pediatric procedural sedation in the emergency department. Pediatr Emerg Care. 2008 Aug;24(8):529-33. doi: 10.1097/PEC.0b013e318180fdb5.

  PMID: 18645539 BACKGROUND

• Cravero JP, Askins N, Sriswasdi P, Tsze DS, Zurakowski D, Sinnott S. Validation of the Pediatric Sedation State Scale. Pediatrics. 2017 May;139(5):e20162897. doi: 10.1542/peds.2016-2897.

  PMID: 28557732 BACKGROUND

MeSH Terms

Conditions

Learning Disabilities

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

dean of faculty of medicine, MD

CONTACT

0020224821894; dean@med.asu.edu.eg

vice of research of fuclty of medicine

CONTACT

0020226857539; viced.research@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: surgeon who are providing medical procedure and nurse who records vital data and level of sedation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of aneathesia

Model Details: 2 groups of children aged 4-12 years with mental disabilities(autism,down syndrome,cerebral palsy)

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: March 4, 2019
• Study Start: March 6, 2019
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 8, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)