A randomized controlled trial comparing pre-incision intravenous ketorolac versus placebo to reduce intraoperative fentanyl consumption in pediatric patients undergoing open unilateral inguinal hernia repair
Phase 4
Active, not recruiting
- Conditions
- Pain after open hernia surgery in pediatric patientsHernia surgery, Pediatric patients, Pain, Ketorolac
- Registration Number
- TCTR20230919002
- Lead Sponsor
- Khon Kaen University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
1. Children aged more than 2 years old, but less than 7 years old
2. ASA classification I-II
3. Undergoing open unilateral inguinal hernia repair
Exclusion Criteria
1. Parents refusal
2. History of allergy to study drugs
3. History of coagulopathy or thrombocytopenia
4. History of asthma or respiratory symptoms
5. History of chronic pain condition or opioids prescription
6. History of GI bleeding or gastric pain
7. Clinically significant renal or hepatic disease: patients who have abnormal renal function and/or abnormal liver function test or have history of renal/liver disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intraoperative cumulative fentanyl consumption Intraoperative period Anesthetic record
- Secondary Outcome Measures
Name Time Method -Pain score during PACU stay At at 0, 30, 60 minutes postoperatively Face, Legs, Activities, Cry, Consolability pain scale,Cumulative fentanyl consumption during PACU stay PACU stay PACU record,Intraoperative bleeding Intraoperative period Suction bottle, gauze, and swab,Incidence of opioids' side effects PACU stay Sedation score, respiratory depression, nausea and vomiting