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Ketamine-ketorolac Versus Fentanyl- Ketorolac I.M in Children During Bone Marrow Biopsy

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ClinicalTrials.gov Identifier: NCT03649334
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Tracking Information
First Submitted Date  ICMJE August 18, 2018
First Posted Date  ICMJE August 28, 2018
Last Update Posted Date September 9, 2020
Actual Study Start Date  ICMJE August 26, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
Postoperative pain [ Time Frame: for 60 minutes later admission to the post-anaesthesia care unit ]
Postoperative pain will be assessed by the CHEOP scale (Children's Hospital of Eastern Ontario Pain Scale)The scale includes six entries with an appropriate point evaluation focused on the character of crying (1-3 points), facial expressions (0-2 points), verbal reaction (0-2 points), position of the body (1-2 points), touch (1-2 points), and position of the legs (1-2 points). Minimum score is 4 (no pain) and maximum is 13 (maximum pain). Grades are summed together. CHEOPS has a minimum possible score of 4 points (no pain) to a maximum of 13 points (the worst pain). When the postoperative pain score exceeded four, rescue analgesia was given with a 20mg/kg paracetamol suppository.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
  • Heart rate [ Time Frame: at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes ]
    Heart rate (beat/minute) using ECG monitoring
  • systolic blood pressure [ Time Frame: at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes ]
    systolic blood pressure (mmHg) using sphygmomanometer cuff
  • The time to the first demand for rescue analgesic [ Time Frame: during first 24 hours postoperative ]
    The time to the first demand for rescue analgesic (minutes or hours)
  • total number of children who required postoperative pain medication [ Time Frame: for 24 hours after surgery ]
  • emergence behavior [ Time Frame: every 5 minutes during first 30 minutes of recovery ]
    -emergence behavior will be measured using Aono's four point scale : (1) Asleep; (2) Awake but calm; (3) Agitated but consolable; and (4) Severely agitated and difficult to console and the highest-recorded value was recorded during the Post anesthesia care unit stay. Lowest score is 1 and highest score is 4 The higher score indicates more emergence agitation. For purposes of analysis, grades 1 and 2 in the scale of behavior were considered no agitation and grades 3 and 4 were considered the presence of agitation.
  • nausea, vomiting [ Time Frame: during first 24 hours postoperative ]
    Number of attacks of nausea and/or vomiting
  • respiratory difficulty [ Time Frame: during first 24 hours postoperative ]
    signs of respiratory difficulty:
    1. Breathing rate. An increase in the number of breaths per minute (>35 breath/minute)
    2. Increased heart rate.
    3. Color changes. A bluish color seen around the mouth, on the inside of the lips, or on the fingernails
    4. Grunting. A grunting sound can be heard each time the person exhales.
    5. Nose flaring. The openings of the nose spreading open while breathing
    6. Retractions. The chest appears to sink in just below the neck and/or under the breastbone with each breath-
    7. Sweating. There may be increased sweat on the head, but the skin does not feel warm to
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 Ketamine-ketorolac Versus Fentanyl- Ketorolac I.M in Children During Bone Marrow Biopsy
Official Title  ICMJE Analgesic Efficacy of Intra-muscular Ketamine-ketorolac Versus Fentanyl- Ketorolac for Children Undergoing Bone Marrow Biopsy and Aspiration
Brief Summary investigators aim to compare between anaesthetic regimens that included dual-agent (fentanyl and ketorolac) or (ketamine and ketorolac) analgesic therapy
Detailed Description

regarding patient registry; a prior G power analysis was done. Based on the assumption that the pain score in intramuscular ketamine group will be similar to similar to those in previously published data; forty children would be required per group to detect a difference of 30% in CHEOPS pain scores with a power of 90% (α =0.05, β =0.1)

- Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences), program version 22. Distribution of data will be first tested by the Shapiro test. Data will be presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, the unpaired t-test will be used to compare the mean values of both groups. For pain and emergence behaviour scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Condition  ICMJE Hematological Malignancy (Leukemia- Lymphoma)
Intervention  ICMJE
  • Drug: ketamine-ketorolac
    The patient will receive ketamine 0.5mg.kg-1 + ketorolac 1mk.kg-1 in 2 ml syringe intramuscularly.
  • Drug: fentanyl- ketorolac
    The patient will receive fentanyl 1.5ug.kg-1 + ketorolac 1 mg.kg-1 in 2ml syringe intramuscularly
Study Arms  ICMJE
  • ketamine-ketorolac
    The patient will receive ketamine in conjunction with intramuscular ketorolac
    Intervention: Drug: ketamine-ketorolac
  • fentanyl- ketorolac
    The patient will receive fentanyl in conjunction with intramuscular ketorolac
    Intervention: Drug: fentanyl- ketorolac
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 15, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status II

Exclusion Criteria:

  • Any known allergy to the studied drugs.
  • congenital heart disease
  • Any cardiac problems.
  • Use of psychotropic medication
  • mental retardation
  • any organ dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 7 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 NCT03649334
Other Study ID Numbers  ICMJE R/18.06.213
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: Undecided
Responsible Party Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Enas A Abd el Motlb, MD Assisitant Professor
PRS Account Mansoura University
Verification Date September 2020

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