Ignite Creation Date:
2024-05-06 @ 9:30 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02995304
Status:
UNKNOWN
Last Update Posted:
2016-12-16
First Post:
2016-11-02
Brief Title:
Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children
Sponsor:
Dr Soliman Fakeeh Hospital
Organization:
Dr Soliman Fakeeh Hospital
Study Overview
Official Title:
Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 0025 mgkg midazolam IV followed by 01 mgkg 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 0025 gmkg 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 0025 mgkg midazolam IV followed by 01 mgkg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None