Prevention of POV After Paediatric Tonsillectomy

NCT02387918 | Completed Phase 4

• 1 other identifier: SM2015
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Tonsillectomy is one of the most frequently performed surgical procedures in children. It remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk of bleeding, and dehydration due to impaired oral intake. Current medications for POV have limited efficacy and may even be associated with potential side-effects. Non-pharmacological techniques such as acupuncture has been investigated as alternatives to antiemetics and as additional treatment modalities for POV.

Conditions

Vomiting

Keywords

Tonsillectomy; postoperative vomiting (POV); Dexamethasone; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Incidence of POV after tonsillectomy with or without adenoidectomy

  by 3 point ordinal scale

  24 hours postoperatively

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.

Drug: Dexamethasone

Acupuncture

ACTIVE COMPARATOR

Acupuncture at point Neiguan (Pericardium-6) bilaterally and at point CV13 (Shang Wen) with acupuncture needles (0.25x25 mm) to a depth of approximately 7 mm will be performed on the children immediately after induction of anaesthesia and removed after 20 minutes

Device: Acupuncture

Interventions

Dexamethasone DRUG

Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.

Dexamethasone

Acupuncture DEVICE

Acupuncture treatment (just after induction of anaesthesia and for approximately 20 minutes)

Acupuncture

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged 2-8 y.
• children ASA 1-2
• tonsillectomy with or without adenoidectomy

You may not qualify if:

• American Society of Anesthesiologists grade greater than or equal to III (patient with severe systemic disease)
• intravenous induction
• contraindication to steroids
• Rash or local infection over an acupuncture point
• administration of steroids in the 24 hours before the surgery
• Use of medication with antiemetic effect within the 24 hours before surgery
• Gastric or intestinal diseases
• refusal of parents

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine Assuit University

Egypt, Assuit, 71111, Egypt

Location

MeSH Terms

Conditions

Vomiting; Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Complementary Therapies; Therapeutics

Study Officials

• Seham Ibrahim, Lecturer

  health,Higher education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 13, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 22, 2016

Record last verified: 2016-01

Locations

EG (1)