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Clinical Trials/CTRI/2018/04/013007
CTRI/2018/04/013007Active, not recruitingNot Applicable

An observational study on chronic postsurgical pain in children following major abdominal surgery

Dr Parul Upreti1 site in 1 country50 target enrollmentStarted: December 15, 2016Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Proportion of children developing chronic post surgical pain at 3 months following major abdominal surgeries

Study Overview

Brief Summary

Chronic postsurgical pain (CPSP) is defined as pain persisting for more than 3 months after the surgery when all other causes of pain have been ruled out. CPSP in children has found to have significant effects on routineactivities like sleep, social activities and school performance. Although it has been studied in adults there is only limited literature available concerning CPSP in children. The incidence of CPSP varies from 5 to 22% depending on the type of surgery. Incidence of CPSP for major abdominal surgeries varies from 13 to 22%. Various risk factors include acute postoperative pain, perioperative anxiety, surgical technique, durationand  genetic predisposition.

Since abdominal surgeries are one of the most common surgical procedures performed in routine operation theatre. So we designed this prospective observational study to study the incidence of chronic postsurgical pain in children aged 2 to 8 years following major abdominal surgeries.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
2.00 Year(s) to 8.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA grade I & II children undergoing major abdominal surgeries.

Exclusion Criteria

  • Refusal by the parents of the patient
  • Patients having allergy to any drug.

Outcomes

Primary Outcomes

Proportion of children developing chronic post surgical pain at 3 months following major abdominal surgeries

Time Frame: 3 MONTHS

Secondary Outcomes

  • Severity and character of chronic post surgical pain as determined by Revised Bieri’s Faces Pain Scale and as described by patient or parents respectively
  • Various perioperative factors like acute postoperative pain , perioperative anxiety , surgical technique , duration of surgery and genetic predisposition that can be associated with development of chronic post surgical pain(2 6 12 24 48HOURS)
  • Chronic postsurgical pain trajectory and identifying patients at high risk for development of CPSP(3 MONTHS)

Investigators

Sponsor
Dr Parul Upreti
Sponsor Class
Other [self]

Study Sites (1)

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