Clinical trial NCT01568372: Efficacy of a Nurse Telephone Follow-up on Pain Intensity After Removal of Tonsils in Children
Official title: Efficacy of a Nurse Telephone Follow-up on Post-tonsillectomy Pain Management and Complications in Children: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pediatric
tonsillectomy
pain management
nurse follow-up
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 52
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity scores on the 3rd day after surgery
timeFrame: Pain assessed on the 3rd postoperative day
measure: Pain intensity scores on the 5th day after surgery
timeFrame: Pain assessed on the 5th postoperative day
measure: Pain intensity scores on the 10th day after surgery
timeFrame: Pain assessed on the 10th postoperative day
Secondary outcomes:
measure: postoperative complications
timeFrame: Complications assessed on the following postoperative days: First day, 3rd day, 5th day and 10th day
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Ste.Justine's
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Sylvie Le May, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paquette J, Le May S, Lachance Fiola J, Villeneuve E, Lapointe A, Bourgault P. A randomized clinical trial of a nurse telephone follow-up on paediatric tonsillectomy pain management and complications. J Adv Nurs. 2013 Sep;69(9):2054-65. doi: 10.1111/jan.12072. Epub 2013 Jan 13.