Skip to content

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

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

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230919002
Enrollment
52
Registered
2023-09-19
Start date
2023-08-23
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain after open hernia surgery in pediatric patients Hernia surgery, Pediatric patients, Pain, Ketorolac

Interventions

1 mg/kg of intravenous ketorolac diluted in 0.9% normal saline up to 2 ml before skin incision,Giving placebo as intravenously 2 ml of 0.9% normal saline
Active Comparator Drug,Placebo Comparator No treatment
Ketorolac tromethamine,Control

Sponsors

Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Intraoperative cumulative fentanyl consumption Intraoperative period Anesthetic record

Secondary

MeasureTime frame
- 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

Countries

Thailand

Contacts

Public ContactPeerapong Sangsungnern

Faculty of Medicine, Khon Kaen University

peersa@kku.ac.th043348390

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026