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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Paquette, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01568372
First received: March 26, 2012
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention
Pain
Other: Telephone follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Efficacy of a Nurse Telephone Follow-up on Post-tonsillectomy Pain Management and Complications in Children: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Pain intensity scores on the 3rd day after surgery [ Time Frame: Pain assessed on the 3rd postoperative day ] [ Designated as safety issue: No ]
    Mean pain intensity score on the 3rd postoperative day (POD)

  • Pain intensity scores on the 5th day after surgery [ Time Frame: Pain assessed on the 5th postoperative day ] [ Designated as safety issue: No ]
    Mean pain intensity score on the 5th postoperative day (POD)

  • Pain intensity scores on the 10th day after surgery [ Time Frame: Pain assessed on the 10th postoperative day ] [ Designated as safety issue: No ]
    Mean pain intensity score on the 10th postoperative day (POD)


Secondary Outcome Measures:
  • postoperative complications [ Time Frame: Complications assessed on the following postoperative days: First day, 3rd day, 5th day and 10th day ] [ Designated as safety issue: Yes ]
    Assess complications and adverse events at each time points of the study


Enrollment: 52
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Other: Telephone follow-up
The intervention group received a telephone follow-up by a nurse on the 1st, 3rd, 5th and 10th postoperative day.
Other Names:
  • Nursing interventions
  • Nursing follow-up
No Intervention: Standard care group
This group received the standard care which consisted of an informative session before discharge and no follow-up once discharged home.
Other: Telephone follow-up
The intervention group received a telephone follow-up by a nurse on the 1st, 3rd, 5th and 10th postoperative day.
Other Names:
  • Nursing interventions
  • Nursing follow-up

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

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01568372

Locations
Canada, Quebec
CHU Ste.Justine's
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Sylvie Le May, PhD Université de Montréal
  More Information

No publications provided by St. Justine's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julie Paquette, Nurse Clinician Specialist, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01568372     History of Changes
Other Study ID Numbers: Tonsils
Study First Received: March 26, 2012
Last Updated: March 30, 2012
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
pediatric
tonsillectomy
pain management
nurse follow-up

ClinicalTrials.gov processed this record on October 19, 2014