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

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ClinicalTrials.gov Identifier: NCT03860831
Recruitment Status : Unknown
Verified March 2019 by Sanaa Farag Mahmoud Wasfy, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : March 4, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sanaa Farag Mahmoud Wasfy, Ain Shams University

Tracking Information
First Submitted Date  ICMJE November 12, 2018
First Posted Date  ICMJE March 4, 2019
Last Update Posted Date March 8, 2019
Actual Study Start Date  ICMJE March 6, 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
change in sedation level after intranasal or intramuscular ketamine midazolam mixture administration. [ Time Frame: every 10 minutes through the study till one hour after 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
parents satisfaction [ Time Frame: two hours after administration ]
image form of 5 point likert scale. 5-very satisfied 4-Satisfied 3-Neither satisfied nor dissatisfied 2-Dissatisfied 1-Very dissatisfied least score is 1 and highest score is 5
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Ketamine and Midazolam Mixture for Procedural Sedation in Children With Mental Disabilities:
Official Title  ICMJE Lecturer of Anesthesia ,Intensive Care and Pain Management in Faculty of Medicine Ain Shams University
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
Detailed Description

Sedation and analgesia decreases the need for general anesthesia outside the operating room. Intravenous route is the standard way of sedation, but its use can be limited in uncooperative mentally disabled children. Active Physical restraint of children causes emotional trauma for both parents and children particularly in these patients. Oral sedation has multiple disadvantages as delayed onset of action, better taste, the need of different types of syrup or honey according to the preference of the patient, children may refuse to take oral drugs or even spit it and it also causes postoperative nausea and vomiting. In contrast, intramuscular sedation is an easy effective way of administration and it is preferred due to its rapid onset of action and higher predictability of the duration, however, fear of the pain of injections is considered a disadvantage in this vulnerable pediatric patients. nasal route is an important alternative route because it is a painless and needless approach with rapid drug absorption from nasal mucosa reaching the cerebrospinal fluid and bypassing the first pass metabolism in the liver. Intranasal midazolam for sedation of children was first described by Wilton et al .Recently studies proved the use of nasal ketamine spray for treatment of resistant depression in adults. Ketamine as a premedication in children has been also successfully given through the nasal route. In Ain shams University hospitals we give either oral Midazolam or intramuscular Ketamine followed by sevoflurane or propofol for pediatric procedural sedation. Nasal Midazolam or Ketamine has not been tried despite being a feasible choice with many possible advantages. Combination of ketamine and midazolam causes deeper sedation and less dysphoric reaction of ketamine so in this study, we evaluate the efficacy and safety of administration of this combination through intranasal route for procedural sedation in children with mental developmental delay outside the operating room.

After approval from our Ethical Committee, written informed consent from the parents will be taken. Forty children presented with autism,mongolism or cerebral palsy classified as American Society of Anesthesiologists (ASA) physical status I and II, aged between 4 and 12 years will be enrolled in our study, and computer-generated assignment will be used for randomization and to allocate patients to one of two equal study groups.

patients will fulfill the fasting hours if elective while the patients in ER will be asked to wait for six hours after last meal.

Patients will be divided into two groups Group IN:will receive intranasal ketamine 5 mg/kg and midazolam 0.2 mg/kg, and we will give intranasal sedatives by using mucosal atomisation device.

Group IM:will receive intramuscular ketamine 5 mg/kg, and midazolam 0.2 mg/kg Sedation levels after 10, 20, and 30 min will be evaluated by Pediatric Sedation State Scale (PSSS).

Drugs will be given 15- 20 minutes before procedure then Heart rate (HR), Oxygen saturation (Spo2), and mean arterial blood pressure (MBP) will be continuously monitored and recorded every 5 min after drug administration for 60 minutes .

Local anesthesia will be given in painful procedures. Intravenous ketamine 1 mg/kg will be given if needed due to prolongation of procedure or if required sedation level not reached through intranasal or intramuscular route.

respiratory events as airway obstruction and desaturation less than 92% will be treated by jaw thrust and oxygen supplementation, apnea or laryngeal spasm will be managed with endotracheal intubation. Wheezing will be recorded and properly managed with bronchodilators and steroids.

Emergency cart and drugs will be available for haemodynamic and respiratory instabilities.

After recovery of the patients, parents and doctors will rate their overall satisfaction by using simple image of 5 point Likert scale.

Primary outcome: effectiveness of sedation. Secondary outcome: onset, duration of sedation, adverse effect, parents and doctor satisfaction.

End point of the study: if our technique failed to sedate the patients general anesthesia will be given either intravenous ketamine 1mg/kg or inhalational sevoflurane to complete the procedure.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
2 groups of children aged 4-12 years with mental disabilities(autism,down syndrome,cerebral palsy)
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description:
surgeon who are providing medical procedure and nurse who records vital data and level of sedation
Primary Purpose: Other
Condition  ICMJE Procedural Sedation
Intervention  ICMJE Drug: Ketamine + midazolam
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.
Other Name: ketalar +dormicum
Study Arms  ICMJE
  • Experimental: intranasal (IN)

    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

    Intervention: Drug: Ketamine + midazolam
  • Active Comparator: intramuscular (IM)

    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.

    Intervention: Drug: Ketamine + midazolam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 28, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Inclusion criteria of the patients were:
  • Mentally affected children (autism,down syndrome and cerebral palsy)
  • children who are scheduled for Short procedures (30 minutes or less) under sedation

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03860831
Other Study ID Numbers  ICMJE R 57/2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sanaa Farag Mahmoud Wasfy, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP