Comparison of Pain Scores by Using Audiovisual Aids.

NCT05452967 | Unknown DMC

• 1 other identifier: 2172-14474
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted at post anaesthesia care unit of Department of Anesthesiology, Aga Khan University Hospital Karachi. The aim of this study is to compare the post operative analgesia between two groups of post operative paediatric patients, Conventional group, receiving conventional analgesia and the group of patients in which distraction technique will be used. Conventional group will only receive conventional analgesia while the distraction group will receive conventional analgesia as well as distraction technique. Distraction technique that will be used is a non-pharmacological method of pain relief for post-operative paediatric patients in post anesthesia care unit. (games on tablets, listening poems, watching cartoons). Conventional analgesia is the standardise rescue analgesia of intravenous administration of analgesics in post anaesthesia care unit prescribed. The analgesia will include I/V Tramadol 0.5 to 1mg/kg and Paracetamol 10mg/kg). Our primary outcome will be pain scores using Wong-Baker FACES® pain rating scale and parent's satisfaction as secondary outcome.

Conditions

Postoperative Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Comparison of pain scores by using audiovisual distraction aids in post operative paediatric patients.

  The pain scores will be assessed in post anaesthesia care unit by using Wong Baker FACES pain rating scale. This scale comprises of a series of faces ranging from a happy face at "0" or "no hurt" to a crying face at "10" which represents the worst pain imaginable. The higher the score the worse will be the pain. We will use a proforma for data collection and for measuring the desired outcome.

  Baseline data (hemodynamic variables and pain score) on arrival in the post anaesthesia care unit . First reading at 15 minutes after intervention. Second at 30 minutes and last at 45 minutes. All the readings will be compared with the initial baseline.

Secondary Outcomes (1)

• Comparison of pain scores by using audiovisual distraction aids in post operative paediatric patients.

  After concluding /last reading at 45 minutes parents satisfaction will be assessed.

Study Arms (2)

Conventional analgesia group Group C

NO INTERVENTION

this group will receive rescue analgesia as per need

Distraction group: Group CD

EXPERIMENTAL

This group will be distracted with the help of mobile or tablet and then will assess that rescue analgesia will be needed in post anaesthesia care unit or not

Other: Distraction technique

Interventions

Distraction technique OTHER

The post operative pediatric patients will be given mobile phone in recovery for plying games and watching cartoons and with the help of this distraction technique will assess that routine rescue analgesia is needed or not

Distraction group: Group CD

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All elective cases on pediatric lists including Orthopaedics, plastic surgery, paediatrics surgery.
• ASA level I and II with age range between 3 and 7 years will be included in the study.

You may not qualify if:

• All pediatric patients who are neurologically challenged,
• Undergoing head and neck surgery,
• Patients undergoing emergency surgery,
• cases with difficult airway,
• language barrier and whose parents have not consented to participate in the study will be excluded.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Shemila Abbasi, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shemila Abbasi, FCPS

CONTACT

92134862896; shemila.abbasi@aku.edu

Saima Rashid, FCPS

CONTACT

92134864637; saima.rashid@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Group C (conventional analgesia group) Group CD (conventional analgesia plus distraction technique)

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: July 12, 2022
• Study Start: April 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 8, 2023
• Last Updated: March 28, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)