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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 : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:
investigators aim to compare between anaesthetic regimens that included dual-agent (fentanyl and ketorolac) or (ketamine and ketorolac) analgesic therapy

Condition or disease Intervention/treatment Phase
Hematological Malignancy (Leukemia- Lymphoma) Drug: ketamine-ketorolac Drug: fentanyl- ketorolac Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Analgesic Efficacy of Intra-muscular Ketamine-ketorolac Versus Fentanyl- Ketorolac for Children Undergoing Bone Marrow Biopsy and Aspiration
Estimated Study Start Date : August 26, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
ketamine-ketorolac
The patient will receive ketamine in conjunction with intramuscular ketorolac
Drug: ketamine-ketorolac
The patient will receive ketamine 0.5mg.kg-1 + ketorolac 1mk.kg-1 in 2 ml syringe intramuscularly.

fentanyl- ketorolac
The patient will receive fentanyl in conjunction with intramuscular ketorolac
Drug: fentanyl- ketorolac
The patient will receive fentanyl 1.5ug.kg-1 + ketorolac 1 mg.kg-1 in 2ml syringe intramuscularly




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. total number of children who required postoperative pain medication [ Time Frame: for 24 hours after surgery ]
  5. 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.

  6. nausea, vomiting [ Time Frame: during first 24 hours postoperative ]
    Number of attacks of nausea and/or vomiting

  7. 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



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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649334


Contacts
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Contact: Enas A Abd el Motlb, MD 00201005401236 ext 00201005401236 sevo2006@gmail.com
Contact: Said Emam, MD sayedemam04@gmail.com

Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Enas A Abd el Motlb, MD Assisitant Professor

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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03649334     History of Changes
Other Study ID Numbers: R/18.06.213
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Ketamine
Fentanyl
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
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors