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Clinical Trials/CTRI/2024/02/063210
CTRI/2024/02/063210Not yet recruitingUnknown

Effect of pregabalin premedication on emergence agitation in pediatric infraumblical abdominal surgery after sevoflurane anesthesia , double blinded, randomized placebo control study.

All India institute of medical sciences Raipur1 site in 1 country80 target enrollmentStarted: March 4, 2024Last updated:

Trial Snapshot

Phase
Unknown
Status
Not yet recruiting
Enrollment
80
Locations
1
Primary Endpoint
Oral pregabalin premedication is effective in Emeregence Agitation after Sevoflurane anesthesia

Study Overview

Brief Summary

Emergence agitation (EA) is a temporary condition that occurs while awaking from general anesthesia.

Sevoflurane is very valuable for induction and continuation of anesthesia in pediatrics, but it is correlated with increased ratio of EA.

Medications used to prevent EA may have unwanted adverse effects such as vomiting and delayed recovery.

Pregabalin belongs to gabapentinoid compounds with anticonvulsant, pain killing, and antianxi-ety activity. The target of this study is to define the influence of pregabalin premedication in pe-

diatrics on EA after sevoflurane anesthesia.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
4.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1 Age: 4-12years 2 mASA physical status 3 Child undergoing Infraumblical Abdominal surgery.

Exclusion Criteria

  • 1 Patient’s parent’s refusal 2 History of developmental delay or mental retardation,which will make observational pain intensity assessment difficult 3 Anatomical abnormalities 4 Bleeding diathesis 5 Coagulation disorder 6 History of renal,hepatic,cardiac disorder upper or lower infection or any neurological abnormalities 7 Emergency cases 8 Cerebral palsy.

Outcomes

Primary Outcomes

Oral pregabalin premedication is effective in Emeregence Agitation after Sevoflurane anesthesia

Time Frame: Day 0 at baseline

in Infraumblical abdominal surgeries.

Time Frame: Day 0 at baseline

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Himanshi

All India institute of medical sciences , Raipur

Study Sites (1)

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