search
Back to results

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

Primary Purpose

Hematological Malignancy (Leukemia- Lymphoma)

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
ketamine-ketorolac
fentanyl- ketorolac
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hematological Malignancy (Leukemia- Lymphoma)

Eligibility Criteria

2 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ketamine-ketorolac

fentanyl- ketorolac

Arm Description

The patient will receive ketamine in conjunction with intramuscular ketorolac

The patient will receive fentanyl in conjunction with intramuscular ketorolac

Outcomes

Primary Outcome Measures

Postoperative pain
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

Heart rate
Heart rate (beat/minute) using ECG monitoring
systolic blood pressure
systolic blood pressure (mmHg) using sphygmomanometer cuff
The time to the first demand for rescue analgesic
The time to the first demand for rescue analgesic (minutes or hours)
total number of children who required postoperative pain medication
emergence behavior
-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
Number of attacks of nausea and/or vomiting
respiratory difficulty
signs of respiratory difficulty: Breathing rate. An increase in the number of breaths per minute (>35 breath/minute) Increased heart rate. Color changes. A bluish color seen around the mouth, on the inside of the lips, or on the fingernails Grunting. A grunting sound can be heard each time the person exhales. Nose flaring. The openings of the nose spreading open while breathing Retractions. The chest appears to sink in just below the neck and/or under the breastbone with each breath- Sweating. There may be increased sweat on the head, but the skin does not feel warm to

Full Information

First Posted
August 18, 2018
Last Updated
September 6, 2020
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT03649334
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 26, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancy (Leukemia- Lymphoma)

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ketamine-ketorolac
Arm Type
Other
Arm Description
The patient will receive ketamine in conjunction with intramuscular ketorolac
Arm Title
fentanyl- ketorolac
Arm Type
Other
Arm Description
The patient will receive fentanyl in conjunction with intramuscular ketorolac
Intervention Type
Drug
Intervention Name(s)
ketamine-ketorolac
Intervention Description
The patient will receive ketamine 0.5mg.kg-1 + ketorolac 1mk.kg-1 in 2 ml syringe intramuscularly.
Intervention Type
Drug
Intervention Name(s)
fentanyl- ketorolac
Intervention Description
The patient will receive fentanyl 1.5ug.kg-1 + ketorolac 1 mg.kg-1 in 2ml syringe intramuscularly
Primary Outcome Measure Information:
Title
Postoperative pain
Description
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.
Time Frame
for 60 minutes later admission to the post-anaesthesia care unit
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate (beat/minute) using ECG monitoring
Time Frame
at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes
Title
systolic blood pressure
Description
systolic blood pressure (mmHg) using sphygmomanometer cuff
Time Frame
at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes
Title
The time to the first demand for rescue analgesic
Description
The time to the first demand for rescue analgesic (minutes or hours)
Time Frame
during first 24 hours postoperative
Title
total number of children who required postoperative pain medication
Time Frame
for 24 hours after surgery
Title
emergence behavior
Description
-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.
Time Frame
every 5 minutes during first 30 minutes of recovery
Title
nausea, vomiting
Description
Number of attacks of nausea and/or vomiting
Time Frame
during first 24 hours postoperative
Title
respiratory difficulty
Description
signs of respiratory difficulty: Breathing rate. An increase in the number of breaths per minute (>35 breath/minute) Increased heart rate. Color changes. A bluish color seen around the mouth, on the inside of the lips, or on the fingernails Grunting. A grunting sound can be heard each time the person exhales. Nose flaring. The openings of the nose spreading open while breathing Retractions. The chest appears to sink in just below the neck and/or under the breastbone with each breath- Sweating. There may be increased sweat on the head, but the skin does not feel warm to
Time Frame
during first 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enas A Abd el Motlb, MD
Organizational Affiliation
Assisitant Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University
City
Mansourah
State/Province
DK
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs