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The efficacy of ketamine in reducing postoperative pain in children undergoing cleft palate (CP) surgery

The efficacy of ketamine in reducing postoperative pain in children undergoing cleft palate (CP) surgery

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221024001
Enrollment
46
Registered
2022-10-24
Start date
2022-11-01
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

Cleft palate Cleft palate surgery , ketamine, paediatric, postoperative pain

Interventions

Ketamine 0.5 mg/kg IV bolus pre-incision,intravenous NSS
Active Comparator Drug,Placebo Comparator No treatment
Ketamine 0.5 mg/kg IV bolus pre-incision,NSS

Sponsors

Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
9 Months to 6 Years

Inclusion criteria

Inclusion criteria: Children age of 9 months to 6 years, ASA I to II, Undergoing elective palatoplasty and palatoplasty with other surgery e.g., cheiloplasty, myringotomy, etc.

Exclusion criteria

Exclusion criteria: Parents refusal, Children with mental retardation, Patient with contraindication of ketamine e.g., uncontrolled hypertension, increase intracranial pressure, increase intraocular pressure, etc., History of allergy to any of the study drugs, Chronic pain syndrome

Design outcomes

Primary

MeasureTime frame
Pain score 0,15,30,45,60 minute post-operative FLACC scale

Secondary

MeasureTime frame
Hemodynamic effect of ketamine 0,5,10,15,30 minute after drudged administration BP, HR, MAP,Time to first analgesic requirement in PACU minutes,Total analgesic consumption at PACU in PACU Total fentanyl administration in mcg IV,Emergence time time after discontinuation of anesthesia to successful extubation minute,Incidence of emergence delirium in PACU PAED score,Incidence of postoperative nausea and vomitting (PONV) in PACU dry heaves, nausea, vomitting,Parent's satisfaction in PACU rating score of 0-10

Countries

Thailand

Contacts

Public ContactBusapun Sermdumrongsak

Faculty of Medicine, Khon Kaen University

busase@kku.ac.th0956076919

Outcome results

None listed

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