跳至主要内容
临床试验/NCT01568372
NCT01568372已完成不适用

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

St. Justine's Hospital2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2010年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
2
主要终点
Pain intensity scores on the 3rd day after surgery

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Abused cases
  • Children with a cognitive deficit
  • Children suffering from chronic pain
  • Child who had another surgical procedure within a month

研究组 & 干预措施

Nurse telephone follow-up

Experimental

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

干预措施: Telephone follow-up (Other)

Standard care group

No Intervention

This group received the standard care which consisted of an informative session before discharge and no follow-up once discharged home.

结局指标

主要结局

Pain intensity scores on the 3rd day after surgery

时间窗: Pain assessed on the 3rd postoperative day

Mean pain intensity score on the 3rd postoperative day (POD)

Pain intensity scores on the 10th day after surgery

时间窗: Pain assessed on the 10th postoperative day

Mean pain intensity score on the 10th postoperative day (POD)

Pain intensity scores on the 5th day after surgery

时间窗: Pain assessed on the 5th postoperative day

Mean pain intensity score on the 5th postoperative day (POD)

次要结局

  • postoperative complications(Complications assessed on the following postoperative days: First day, 3rd day, 5th day and 10th day)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie Paquette

Nurse Clinician Specialist

St. Justine's Hospital

研究点 (2)

Loading locations...

相似试验