Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children
Primary Purpose
Preoperative Sedation, Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Morphine premedication
Midazolam premedication
Saline premedication (placebo)
Sponsored by
About this trial
This is an interventional prevention trial for Preoperative Sedation
Eligibility Criteria
Inclusion Criteria:
- Tonsillectomy procedures in
- Children aged between 7 and 12 years old.
Exclusion Criteria:
Bronchial asthma, obstructive sleep apnea, allergy to medications used in the study and those who are unfit for surgery or anesthesia for any reason like coagulopathy or chest infection.
Sites / Locations
- Doctor Soliman Fakeeh Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Morphine and Midazolam premedication
Midazolam only premedication
Arm Description
30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine 20 to 30 min before surgical incision.
30 children who will receive 0.025 mg/kg midazolam IV followed by saline 20 to 30 min before surgical incision.
Outcomes
Primary Outcome Measures
Postoperative morphine requirement
Secondary Outcome Measures
Postoperative nonsteroidal analgesic requirements
Preoperative behavior score
B. Behavior scores:
1 - Calm and cooperative 2 - Anxious but can be reassured 3 - Anxious and can not be reassured 4 - Crying, or resisting C. Wake-up behavior scores 1 - Calm and cooperative 2 - Not calm but could be easily calmed 3 - Not easily calmed, moderately agitated or restless 4 - Combative, excited, disoriented.
Wake-up behavior scores
Full Information
NCT ID
NCT02995304
First Posted
November 2, 2016
Last Updated
December 13, 2016
Sponsor
Dr. Soliman Fakeeh Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02995304
Brief Title
Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children
Official Title
Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Soliman Fakeeh Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this double blind study, after taking an informed consent, 60 children aged between 7 and 12 years old assigned for tonsillectomy with or without adenoidectomy will be randomly divided into three groups. The first group 30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision. In the second group30 children who will receive the same dose of midazolam followed by saline premedication. All groups will be compared for pain score using visual analog scale (VAS) after recovery and hourly for 8 hours and during first drinking. Heart rate (HR), blood pressure and peripheral oxygen saturation (SPO2) will be recorded before premedication, every 10 min after premedication then every 5 min during and after anesthesia. 6 point sedation score and 4 points behavioral score will be monitored every 5 min after sedation. Four-point wake-up score will be recorded every 5 min. Time of first analgesic requirement and total morphine consumption during the first post-operative 8 hours will be recorded.
Detailed Description
Tonsillectomy is a minor procedure but it causes sever post-operative pain. This pain is difficult to be controlled with opioids because the fear from respiratory depression in pediatric age group with postoperative oral bleeding. The World Heath Organization (WHO) guidelines clearly state that fear and lack of knowledge regarding the use of opioids in children should not be a barrier for effective analgesia (1). ). However, these procedures are usually day case and the use of oral morphine at home may be risky in some groups of this population (2). So decrease the analgesic requirements following these procedures will increase both satisfaction and safety. The trials for the use of morphine as a preemptive analgesia, in awake patient, have been limited to intramuscular (IM) or oral use which has a slow onset and unpredictable absorption. The use of preoperative IV morphine is not popular because of the unpleasant sensations following its administration. I will use small dose midazolam 0.025 gm/kg before morphine to prevent this sensation. In this double blind study, after taking an informed consent, 60 children aged between 7 and 12 years old assigned for tonsillectomy with or without adenoidectomy will be randomly divided into three groups. The first group 30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision. In the second group30 children who will receive the same dose of midazolam followed by saline premedication. Inhalational anesthesia with sevoflurane and nitrous oxide will be used in all patients. Exclusion criteria are those with bronchial asthma, obstructive sleep apnea, allergy to medications used in the study and those who are unfit for surgery or anesthesia for any reason like coagulopathy or chest infection.
All groups will be compared for pain score using visual analog scale (VAS) after recovery and hourly for 8 hours and during first drinking. HR, blood pressure and SPO2 will be recorded before premedication, every 10 min after premedication then every 5 min during and after anesthesia. 6 point sedation score and 4 points behavioral score will be monitored every 5 min after sedation. Four-point wake-up score will be recorded every 5 min. Time of first analgesic requirement and total morphine consumption during the first post-operative 8 hours will be recorded. Base line oxygen saturation, incidence of postoperative hypoxia, bleeding, nausea and vomiting will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Sedation, Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morphine and Midazolam premedication
Arm Type
Active Comparator
Arm Description
30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine 20 to 30 min before surgical incision.
Arm Title
Midazolam only premedication
Arm Type
Active Comparator
Arm Description
30 children who will receive 0.025 mg/kg midazolam IV followed by saline 20 to 30 min before surgical incision.
Intervention Type
Drug
Intervention Name(s)
Morphine premedication
Intervention Description
30 children will 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision.
Intervention Type
Drug
Intervention Name(s)
Midazolam premedication
Intervention Description
All children who will receive 0.025 mg/kg midazolam IV as a premedication 20 to 30 min before surgical incision.
Intervention Type
Drug
Intervention Name(s)
Saline premedication (placebo)
Intervention Description
30 children in midazolam only group will receive saline after midazolam
Primary Outcome Measure Information:
Title
Postoperative morphine requirement
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Postoperative nonsteroidal analgesic requirements
Time Frame
two days
Title
Preoperative behavior score
Description
B. Behavior scores:
1 - Calm and cooperative 2 - Anxious but can be reassured 3 - Anxious and can not be reassured 4 - Crying, or resisting C. Wake-up behavior scores 1 - Calm and cooperative 2 - Not calm but could be easily calmed 3 - Not easily calmed, moderately agitated or restless 4 - Combative, excited, disoriented.
Time Frame
15 to 30 minutes
Title
Wake-up behavior scores
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Tonsillectomy procedures in
Children aged between 7 and 12 years old.
Exclusion Criteria:
Bronchial asthma, obstructive sleep apnea, allergy to medications used in the study and those who are unfit for surgery or anesthesia for any reason like coagulopathy or chest infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr A Keera, MD
Phone
00966544639362
Email
amrkeera@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr A Keera, MD
Organizational Affiliation
Doctor Soliman Fakeeh Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Doctor Soliman Fakeeh Hospital
City
Jeddah
ZIP/Postal Code
21461
Country
Saudi Arabia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr A Keera, MD
Phone
00966544639362
Email
amrkeera@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children
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