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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Other: Telephone follow-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse telephone follow-up<br>This group received a telephone follow-up by a nurse following discharge from the hospital and up until the 10th postoperative day, which is considered as the usual period of healing for a tonsillectomy | Other: Telephone follow-up<br>* The intervention group received a telephone follow-up by a nurse on the 1st, 3rd, 5th and 10th postoperative day.<br>* Other names: Nursing follow-up;|
| No Intervention: Standard care group<br>This group received the standard care which consisted of an informative session before discharge and no follow-up once discharged home. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, tonsillectomy, pain management, nurse follow-up