Efficacy of Peritonsillar Dexmedetomidine Infiltration for Postadenotonsillectomy Pain

NCT02013570 | Completed Phase 4

• 1 other identifier: 2013/556
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the present study is the clinical assessment of the efficacy of preincisional peritonsillar infiltration of dexmedetomidine on postoperative pain relief in children undergoing adenotonsillectomy.

Conditions

Pain Postoperative, Intraoperative Hemorrhage

Keywords

postoperative pain; dexmedetomidine; adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

• post adenotonsillectomy pain

  Modified Hannallah pain scale, nausea, vomiting, bleeding, rescue analgesia, sedation and Aldrete scores were recorded on arrival in the postanesthesia care unit, at 15th, 30th, 60th, 90th and 120th min. Patient with pain scores \>4, for a patient request for pain medication, received 1mg/kg Tramadol drop as supplementary analgesia. The first analgesic requirement time recorded. Agitation was measured with Pediatric anesthesia emergence delirium scale. Patients with an Aldrete score of 9 were transferred to the postoperative surgical ward. Pain, nausea and vomiting, bleeding and sedation were assessed in the postoperative surgical ward. Analgesic requirement were recorded. Pain was measured at rest and with swallowing. All patients were discharged at the end of the day and stayed home at night. Postoperative pain during the first 24 h was assessed using a four-point scale. Patients were interviewed on the day after surgery to ases.

  24 hours

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Group S peritonsillar 2ml normal saline (1 ml per tonsil) via peritonsillar infiltration.

Drug: Dexmedetomidine

Normal saline, postoperative pain

PLACEBO COMPARATOR

Group S peritonsillar 2ml normal saline (1 ml per tonsil) via peritonsillar infiltration.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

2µg/kg dexmedetomidine in 2 ml normal saline (1 ml per tonsil),

Also known as: Precedex

Dexmedetomidine; Normal saline, postoperative pain

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged 3-9 years American Society of Anesthesiologists 1-2 status, scheduled for adenotonsillectomy

You may not qualify if:

• Children with systemic disease, metabolic and endocrin disorders, growth developmental and motor-mental retardation, those who had a history of allergy to any of the study drugs, peritonsillar abscess, hypertension, psychiatric and epileptic disorders, chronic pain syndrome, and those who received analgesics within 24 h prior to surgery were excluded from study.

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Conditions

Pain, Postoperative; Blood Loss, Surgical

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 17, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 17, 2013

Record last verified: 2013-09