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

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

Tracking Information

• First Submitted Date: August 18, 2018
• First Posted Date: August 28, 2018
• Last Update Posted Date: September 9, 2020
• Actual Study Start Date: August 26, 2018
• Actual Primary Completion Date: October 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine-ketorolac Versus Fentanyl- Ketorolac I.M in Children During Bone Marrow Biopsy
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Other
• Condition: Hematological Malignancy (Leukemia- Lymphoma)

Intervention

• 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

• 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

Recruitment Information

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

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 7 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03649334
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: Mansoura University
• Study Sponsor: Mansoura University
• Collaborators: Not Provided

Investigators

• Study Chair: Enas A Abd el Motlb, MD; Assisitant Professor

• PRS Account: Mansoura University
• Verification Date: September 2020