To compare opioid based and opioid free anaesthesia in children undergoing day case surgery

A randomised controlled trial to compare time to discharge readiness after opioid based and opioid free anaesthesia in children undergoing day case surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/048351

Enrollment

Registered

2022-12-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Opioid free anaesthesia : PROPOFOL 3MG/KG AND KETAMINE 0.5MG/KG INTRAVENOUS SINGLE DOSE Control Intervention1: OPIOID BASED ANAESTHESIA: PROPOFOL 3MG/KG AND FENTANYL 1mcg/KG INTRAVENOUS

Eligibility

Inclusion criteria

Inclusion criteria: ELECTIVE DAY CARE SHORT SURGERY SUCH AS INGUINAL HERNIA, VARICOCELE, UNDESCENDED TESTIS, HYDROCELE

Exclusion criteria

Exclusion criteria: ASA III AND ASA IV PATIENTS CHILDREN WITH KNOW ALLERGIES OR CONTRAINDICATION TO EITHER DRUG. SURGERIES MORE THAN 2 HOURS.

Design outcomes

Primary

Measure	Time frame
Mean time to discharge readiness (Ped-PADSS score more than or equal to 9) after opioid based and opioid free anaesthesia in children undergoing day case surgery.Timepoint: baseline, 30min, 60mins, 90mins, 120mins.	—

Secondary

Measure	Time frame
1.Mean (Â±SD) Heart rate (per min) and NIBP (mmHg) intra-operatively. 2. Mean time (minutes) taken to achieve Modified Aldrete score more than or equal to 9. 3. Mean (Â±SD) time (minutes) for rescue analgesia required till the time of discharge. 4. Median (IQR) pain assessment using FLACC score after every half an hour till discharge. 5. Median (IQR) Ramsay sedation scale after the surgery at score after every half an hour till discharge. 2. Proportion of patients developing side effects of drugs used (delirium, psychosis, hallucinations and apnea).Timepoint: every 30 minutes.	—

Measure

Time frame

1.Mean (Â±SD) Heart rate (per min) and NIBP (mmHg) intra-operatively. 2. Mean time (minutes) taken to achieve Modified Aldrete score more than or equal to 9. 3. Mean (Â±SD) time (minutes) for rescue analgesia required till the time of discharge. 4. Median (IQR) pain assessment using FLACC score after every half an hour till discharge. 5. Median (IQR) Ramsay sedation scale after the surgery at score after every half an hour till discharge. 2. Proportion of patients developing side effects of drugs used (delirium, psychosis, hallucinations and apnea).Timepoint: every 30 minutes.

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Countries

India

Contacts

Public ContactDr Anshu Gupta

LADY HARDINGE MEDICAL COLLEGE

anug71@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026