Efficacy of a Nurse Telephone Follow-up on Pain Intensity After Removal of Tonsils in Children

Pain Clinical Trial

Official title:

Efficacy of a Nurse Telephone Follow-up on Post-tonsillectomy Pain Management and Complications in Children: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568372
• Other study ID #: Tonsils
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: October 3, 2017
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: October 2017
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if a nurse telephone follow-up to parents of children who underwent a removal of their tonsils would be effective in reducing pain intensity, complications and resort to other healthcare services

Description:

Tonsillectomy in children is a common elective day surgery. In the United States, 530 000 children under 15 years of age underwent a tonsillectomy in 2006. This minor surgery generates moderate to severe pain and many postoperative complications, both in the early postoperative phase and for at least 7 days. Patients are discharged home a few hours after tonsillectomy, and parents take over their child's care. But not all parents have the ability and knowledge required to adequately manage the pain and complications. This sub-optimal care situation has a significant impact on the child's convalescence and can lead to poor pain management, dehydration, poor rest and sleep quality, nausea, vomiting as well as an increase in the risk of secondary haemorrhage. Many interventions have been evaluated to improve pain management, such as education strategies for parents or children and tools to guide parents. However, none of these strategies have obtained significant results on children's pain intensity post-tonsillectomy.

A nurse telephone follow-up can significantly reduce pain intensity of adults who undergo ambulatory surgery. This intervention is defined as multiple telephone calls made to the patient by a nurse, after discharge, to provide information, and review discharge prescriptions and management of care by the patient himself or by a care-giver. Only a few studies have explored nurse telephone follow-up for children who underwent tonsillectomy. The design of these studies, including the time-periods chosen for data collection, were not properly determined to adequately evaluate the impact of the intervention on management of pain and prevention of postoperative complications. Thus, we planned to determine if a nurse telephone follow-up, made to parents following their child's tonsillectomy, would contribute to decrease pain intensity, incidence of postoperative complications and resort to other healthcare services.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• ASA I or II

• Elective surgery for tonsillectomy

• Parents or children able to read, and understand French or English

• Family equipped with a phone at home

• Child discharged home after the surgery

Exclusion Criteria:

• Abused cases

• Children with a cognitive deficit

• Children suffering from chronic pain

• Child who had another surgical procedure within a month

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Telephone follow-up
The intervention group received a telephone follow-up by a nurse on the 1st, 3rd, 5th and 10th postoperative day.

Locations

Country	Name	City	State
Canada	CHU Ste.Justine's	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity scores on the 3rd day after surgery	Mean pain intensity score on the 3rd postoperative day (POD)	Pain assessed on the 3rd postoperative day
Primary	Pain intensity scores on the 5th day after surgery	Mean pain intensity score on the 5th postoperative day (POD)	Pain assessed on the 5th postoperative day
Primary	Pain intensity scores on the 10th day after surgery	Mean pain intensity score on the 10th postoperative day (POD)	Pain assessed on the 10th postoperative day
Secondary	postoperative complications	Assess complications and adverse events at each time points of the study	Complications assessed on the following postoperative days: First day, 3rd day, 5th day and 10th day