Ahmed Mohamed Hasanin
Cairo, 11432, Egypt
NCT Number: NCT05610384
The aim of this study is to compare the analgesic effect of intravenous ibuprofen to ketorolac for pain control after open hysterectomy
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Notify Me40 year–65 year
Female
Interventional
Not applicable
Cairo, 11432, Egypt
Thirty minutes before the surgery, all patients will receive 1 gm paracetamol intravenously then every 6 hours postoperatively.
A research assistant is responsible for opening the envelopes, group assignment and drug preparation (the three doses will be prepared and marked with the patient's name as well as the time of administration) without any further involvement in the study. The patient, attending anesthetist, nurse and data collector will be blinded to the administered drug.
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 8 mg dexamethasone drugs.
Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 1 mcg/kg fentanyl, and tracheal intubation will be facilitated by 0.5 mg/kg atracurium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg atracurium every 20 minutes. Intraoperative analgesia will be in the form of 1 mcg/kg fentanyl boluses as needed.
Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 2, 4, 6, 10, 18, and 24 h after leaving the operating room. If the VAS score is > 3 intravenous titration of 2 mg morphine given slowly to be repeated after 30 minutes if pain persisted.
Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes before induction of anesthesia then every 8 hours postoperatively
ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes before induction of anesthesia then every 8 hours postoperatively.
Time frame: 24 hour after surgery
average postoperative VAS
Time frame: 30 minutes, 2, 4, 6, 10, 18, 24 hours postoperatively
a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Time frame: procedure (during knee flexion)
a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Time frame: period from extubation until first analgesic requirement during the first 24 hour postoperatively
hours
Time frame: during the first 24 hour postoperatively
mg
Time frame: during the first 24 hour postoperatively
time from extubation to be able independently mobile e.g. using the bathroom
Time frame: at the end of 24 hour postoperative
on scale of 0 to 10
Cairo University
Other
Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy: a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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