The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit

Pain, Postoperative Clinical Trial

Official title:

The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06390007
• Other study ID #: 24916
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Indonesia University
• Contact: Irene Yuniar
• Phone: +6281380327808
• Email: irene.tambunan[@]yahoo.co.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain is an unpleasant sensory and emotional experience resulting from tissue damage. Pain management is typically conducted according to the World Health Organization (WHO) pain management ladder. Analgesics administered to pediatric patients vary in dosage and type, but these analgesics often have significant side effects. The acupuncture technique using press needles is a non-pharmacological pain therapy modality that has been studied for its ability to reduce the use of analgesic drugs, thereby potentially decreasing side effects associated with analgesic use. The study was conducted using a randomized controlled trial (RCT) design involving 70 pediatric postoperative patients aged 1-18 years who were admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital. Subjects were divided into two groups: a control group and an experimental group. The control group received standard analgesic therapy and sham press needle application (a patch resembling a press needle without a needle), while the experimental group received standard analgesic therapy and press needle application at acupuncture points after the patient had been in the Pediatric Intensive Care Unit for 24 hours. Pain scale monitoring was conducted at 1, 6, 24, 48, and 72 hours using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale for children aged 1-8 years, and the Numeric Rating Scale (NRS) for children over 8 years old. This study hypothesizes that the acupuncture technique using press needles can reduce the pain scale in pediatric postoperative patients, leading to a decrease in the use of analgesics and a reduction in side effects associated with analgesic use.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Pediatric postoperative patients admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital
• Aged between 1 and 18 years
• Patients with a platelet count greater than 20,000/mL
• Patients undergoing elective surgery
• Willingness to participate in the study

Exclusion Criteria:

• Patients with a local infection at the puncture site
• Patients with anatomical abnormalities of the outer ear
• Failure to complete the acupuncture therapy
• Patients with chronic illnesses who have previously received analgesic therapy

Related Conditions & MeSH terms

• Pain, Postoperative
• Pediatric Disorder

Intervention

Device:
• Sham press needle
The plester used is a round plaster that resembles the shape of an acupuncture press needle.
• Press needle acupuncture
Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.

Locations

Country	Name	City	State
Indonesia	RSUPN Dr. Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale	The Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale for children aged 1 to 8 years is used to assess pain levels	Pain scale monitoring will be conducted at 1 hour; 6 hours; 24 hours; 48 hours; and 72 hours after the application of sham press needle / press needle acupuncture
Primary	Numeric Rating Scale (NRS) pain scale	The Numeric Rating Scale (NRS) is used to assess pain levels in children over the age of 8.	Pain scale monitoring will be conducted at 1 hour; 6 hours; 24 hours; 48 hours; and 72 hours after the application of sham press needle / press needle acupuncture