Comparison between dexmedetomidine and ketofol in the prevention of postoperative emergence delirium in pediatric patients undergoing orofacial cleft surgery: A randomized controlled trial.
Surabhi, Poonam Kumari, Amarjeet Kumar, Chandni Sinha, Ajeet Kumar, Veena K. Singh
Journal of anaesthesiology, clinical pharmacology 2025 DOI: 10.4103/joacp.joacp_521_23 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 105 |
| Population | Children aged 3 months to 2 years, ASA I and II, scheduled for orofacial cleft surgery |
| Interventions | Dexmedetomidine Normal saline |
| Dose | Dexmedetomidine 0.3 μg/kg; ketofol (ketamine 0.25 mg/kg and propofol 1.0 mg/kg); normal saline |
| Duration | 10 minutes before extubation, with assessments at 0, 10, 20, 30, and 60 minutes after surgery |
| Topics | Ketamine |
| Keywords | Cleft lip Cleft palate Dexmedetomidine Emergence delirium Propofol Pediatric surgery Anesthesia management Postoperative care |
| Citations | 1 |
| Key findings | Dexmedetomidine reduced the incidence of emergence delirium to 20% compared to 29% with ketofol and 49% with saline. |
Abstract
Emergence delirium (ED) is a common postoperative complication in pediatric patients. To avoid postoperative ED, sedative medications have been utilized in addition to general anesthesia. In this study, the primary objective was to assess the incidence of postoperative emergence of delirium at 0-, 10-, 20-, 30-, and 60-min intervals. Secondary objective was to assess postoperative analgesia (0, 10, 20, 30, and 60 min) and hemodynamic parameters (mean arterial pressure, pulse, oxygen saturation). In this randomized controlled study, 105 American Society of Anesthesiologists I and II patients, aged between 3 months and 2 years, scheduled for orofacial cleft surgery were enrolled. Patients of group I received dexmedetomidine (0.3 μg/kg), group II received ketofol (a mixture of ketamine 0.25 mg/kg and propofol 1.0 mg/kg), and group III received normal saline 10 min before extubation. The incidence of postoperative ED using the Watcha scale and the postoperative pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale were recorded. The Watcha scale at the immediate postoperative period and at 10-, 20-, 30-, and 60-min intervals was 0 (1), 1 (1.75), 1 (1), 2 (2), and 3 (2) in group I, 1 (1), 2 (1), 2 (2), 2 (3), and 3 (2) in group II, and 2 (1), 3 (1), 3 (1.25), 4 (1), and 4.5 (1.5) in group III, respectively, at the above time points. On comparing group I with groups II and III, the difference was significant (P < 0.01). The FLACC score at the immediate postoperative period and at 10-, 20-, 30-, and 60-min intervals was 1 (1), 1 (1), 1 (1), 2 (2), and 3 (2) in group I, 2 (2), 2 (1), 2 (2), 2(3), and 3 (2) in group II, and 4 (1), 3 (1), 3 (1.25), 4 (1), and 4.5 (1.5) in group III, respectively, at the above time points. The FLACC score was also lower in group I in comparison to groups II and III. The difference among the groups was significant (P < 0.01). The incidence of postoperative delirium was lower in group I at 20% (7/35) than in group II at 29% (10/35) and in group III at 49% (17/35), and difference among the groups was significant (<0.01). We conclude that both dexmedetomidine and ketofol are effective in reducing postoperative ED. Dexmedetomidine is more effective than ketofol in preventing postoperative ED in the pediatric population.
Comparable studies
Other randomized controlled trials on ketamine, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Subanesthetic Effects of the Noncompetitive NMDA Antagonist, Ketamine, in Humans Healthy human subjects recruited from the community | 1994 | Randomized controlled trial | n = 19 |
| Antidepressant Efficacy of Ketamine in Treatment-Resistant Major Depression: A Two-Site Randomized Controlled Trial Patients with treatment-resistant major depression experiencing a major depressive episode | 2013 | Randomized controlled trial | n = 73 |
| Remifentanil-induced Postoperative Hyperalgesia and Its Prevention with Small-dose Ketamine Patients undergoing major abdominal surgery | 2005 | Randomized controlled trial | n = 75 |
| Efficacy of Intravenous Ketamine for Treatment of Chronic Posttraumatic Stress Disorder Patients with chronic PTSD related to a range of trauma exposures | 2014 | Randomized controlled trial | n = 41 |
| Ketamine-Induced Deficits in Auditory and Visual Context-Dependent Processing in Healthy Volunteers Healthy volunteers | 2000 | Single-blind placebo-controlled study | n = 20 |