Study Comparing Two Doses of Nalbuphine for Reducing Agitation and Pain After Surgery in Children Receiving Sevoflurane Anaesthesia

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Inj. Nalbuphine 0.1 mg/kg Intravenously: Intravenous nalbuphine 0.1 mg/kg, diluted to 10 mL with normal saline, administered slowly over 2 minutes, 10 minutes before extubation in pediatric patients undergoing elective surgery under sevoflurane anesthesia. Standard anesthesia and perioperative care will be identical in both groups. Control Intervention1: 0.1 mg/kg Nalbuphine: 0.2 mg/kg Nalbuphine Control Intervention2: Inj. Nalbuphine 0.1 mg/kg: Nalbuphine hydrochloride is a synthetic narcotic agonist antagonist analgesic. with a duration of analgesia of 4 5hr is used to treat and prevent moderate to severe pain, it can also be used for pain, It has also studied and established that nalbuphine reduces the emergence agitation. Control Intervention3: Inj. Nalbuphine 0.2 mg/kg: Nalbuphine hydrochloride is a synthetic narcotic agonist antagonist analgesic. with a duration of analgesia of 4 5hr is used to treat and prevent moderate to severe pain, It has also studied and established that nalbuphine reduces the emergence agitation, through higher dose comparisons. Control Intervention4: Inj. Nalbuphine 0.2 mg/kg Intravenously: Intravenous nalbuphine 0.2 mg/kg, diluted to 10 mL with normal saline, administered slowly over 2 minutes, 10 minutes before extubation in pediatric patients undergoing elective surgery under sevoflurane anesthesia. Standard anesthesia and perioperative care will be identical in both groups. CONDITION: Health Condition 1: O‐ Medical and Surgical PRIMARY OUTCOME: 1.To compare the incidence and severity of emergence agitation. ; 2.To determine and compare postoperative pain scores.Timepoint: 1.upto 30 mins ; 2.upto 6 hours SECONDARY OUTCOME: 1.To compare time to removal of Supraglottic Airway device. ; 2.To compare the time to emergence. ; 3.To evaluate sedation scores. ; 4.To determine postoperative adverse events if any. ; Timepoint: 1.From end of surgery/skin suturing until SGA removal ; 2.From discontinuation of sevoflurane until spontaneous eye opening ; 3.Every 15 minutes for the first 1 hour in PACU ; 4.During the postoperative/PACU observation period INCLUSION CRITERIA: Age 3‐10 yr old of either of the sex, within normal range of weight, American society of Anesthesiologist Physical status I or II, Elective Surgical procedures with duration of less than 120 mins in supine position
Epistemonikos ID: 13288a386cab0f7d3f85061dd24ee51d9d83434d
First added on: Oct 08, 2026