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

NCT ID: NCT01568372

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-10-31

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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Nurse telephone follow-up

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

Group Type EXPERIMENTAL

Telephone follow-up

Intervention Type OTHER

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

Standard care group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telephone follow-up

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

Intervention Type OTHER

Other Intervention Names

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Nursing interventions Nursing follow-up

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Julie Paquette

Nurse Clinician Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sylvie Le May, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

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CHU Ste.Justine's

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 23311981 (View on PubMed)

Other Identifiers

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Tonsils

Identifier Type: -

Identifier Source: org_study_id