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To study the effect of gabapentin given before surgery on opioid consumption during surgery in children undergoing elective craniotomy

Effect of preoperative gabapentin on intraoperative opioid consumption in children undergoing elective craniotomy: A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/053233
Enrollment
30
Registered
2023-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: C71- Malignant neoplasm of brain Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Gabapentin: Oral Gabapentin as per body weight- 10-20 kg- 100 mg 20-30 kg- 150 mg 30-40 kg- 200 mg 40-50 kg- 250 mg 50-60 kg- 300 mg (each patient receiving a dose of minimum 5mg/kg i

Sponsors

Shruti Pandey
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: all children under 18 yrs will be considered provided they do not fall under the exclusion criteria

Exclusion criteria

Exclusion criteria: Signs and symptoms of raised ICP Children on nasogastric tube feeds Children already on pregabalin or gabapentin preoperatively Children having known allergy to gabapentin or pregabalin Children with renal dysfunction Children with body weight 60 kg

Design outcomes

Primary

MeasureTime frame
Difference in the intraoperative fentanyl requirement in the two groupsTimepoint: at the end of surgery

Secondary

MeasureTime frame
Ease of parental separationTimepoint: Before shifting patient to OT;Pre-operative sedation scoreTimepoint: Before shifting patient to OT;Intraoperative hemodynamic response to noxious stimuliTimepoint: pin insertion, skin incision, dural incision, dural closure, skin closure and extubation;Number of patients who remained intubated at the end of 24 hrsTimepoint: 24 hrs after surgery;Episodes of POV in first 24 hrsTimepoint: 24 hrs after surgery;Pain scores in first 24 hoursTimepoint: 2,4,6,12,24 hrs after surgery;Seizure episodes in first 24 hoursTimepoint: 24 hrs after surgery;Need for rescue analgesia in first 24 hrsTimepoint: 24 hrs after surgery;Nursesâ?? satisfaction scoreTimepoint: 24 hrs after surgery;Patient compliance with study medicationTimepoint: at time of drug administration

Countries

India

Contacts

Public ContactShruti Pandey

All India Institute of Medical Sciences

anaes_sritam@aiimsbhubaneswar.edu.in8951614718

Outcome results

None listed

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