A Phase 2 interventional study of Bupivacain and Ketorolac in Postoperative Pain, Acute, sponsored by Sohag University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Sohag University · Phase 2, Interventional, and Health services research
Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.
Ketorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.
Group (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).
Group (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg)
This prospective randomized controlled study were carried out in Sohag university hospitals after getting approval from medical research ethics committee and written informed consents from the patients' parents or legal guardians. This study included 90 ASA status I and II children aged 6-12 years undergoing elective lower abdominal surgeries.Preoperative assessment:
Before starting, standard monitoring will be as follow:
Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).
Then TAP block were done under ultrasound guidance using either bupivacaine and ketorolac or bupivacaine alone
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 90 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).
Drug: Bupivacain · Drug: Ketorolac
ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg).
Drug: Bupivacain
analgesia
Also known as: bupivacaine
analgesia
1st analgesic requirement
the time at which the 1st need for analgesia is given.
Time frame: 24 hours
Number of patients who requested analgesia
Number (percentage)of patients who requested analgesia
Time frame: 24 hours
heart rate
the patient vital sign (beats/min)
Time frame: 24 hours
Total rescue analgesia
Total rescue analgesia in the first 24 h. postoperatively
Time frame: 24 hours
Satisfaction of the parents regarding their children analgesia
using 5- point satisfaction scale (1= Very satisfied, 2=Satisfied,3= Neither satisfied nor dissatisfied,4= Dissatisfied, 5= Very dissatisfied). This satisfaction will be done by parents according to the VAS, incidence of side effects and analgesic requirements
Time frame: 24 hours
Number of children in each group who required analgesia in the first 24 h postoperatively
Number of children in each group who required analgesia in the first 24h postoperatively
Time frame: 24 hours
blood pressure
The patients blood pressure (mmHg)
Time frame: 24 hours
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Sohag University