The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00472186
• Collaborator: (none)
• Enrollment: 2
• Locations: 2
• Arms: 2
• Actual Duration (Months): 32
• Patient Per Site: 1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study was designed to determine whether post-operative pain following a tonsillectomy can be reduced by adding an antacid-like medication to the medications taken after surgery. It is hypothesized that even a small amount of stomach acid backing up and entering the mouth can increase post-tonsillectomy pain. Therefore, the use of an antacid-like medication should help to decrease pain and reduce the amount of narcotic medication required for pain control.

Condition or Disease	Intervention/Treatment	Phase
Post-tonsillectomy Pain; Post-tonsillectomy Activity; Post-tonsillectomy Hydration	Drug: Lansoprazole; Drug: Placebo	Phase 4

Detailed Description

This study has been limited to children and adolescents ages 5-18 who are undergoing tonsillectomy for an indication of obstructive sleep disturbance (snoring, choking/gasping or pauses in breathing during sleep.)

Study participants will be randomized to two groups: study medication (Lansoprazole) or an inactive substance(placebo).

Participants will be asked to do all of the following:

1. Take the study medication twice a day for 14 days.

2. Keep a log book which will include:

• Record the medications and amount of each medication taken each day for 14 days. This includes pain medication and the study drug.

• Record your child's activity level daily for 14 days.

• Collect your child's urine one time daily and test it using special medicated strips to monitor their daily liquid intake for 14 days.

1. Meet with a Research Assistant or Study Physician 14-21 days after the study to collect the log book and perform a post-operative examination.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effects of Gastro-esophageal Acid Suppression on Post-tonsillectomy Pain
• Actual Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Post-operative administration of Lansoprazole	Drug: Lansoprazole; If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.; Other Names: Prevacid
Placebo Comparator: 2 Placebo	Drug: Placebo; Placebo will also be administered based on weight.

Outcome Measures

Primary Outcome Measures

1. The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication. [2 weeks]

Secondary Outcome Measures

1. The Secondary Outcomes Are the Number of Days to be Free of Pain, the Number of Days to Return to Normal Activity Levels and the Number of Days to Return to Normal Fluid Intake. [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• All healthy children ages 5-18 years scheduled for tonsillectomy and /or adenotonsillectomy for sleep disturbance secondary to airway obstruction at Children's Hospital Boston

Exclusion Criteria:

• Patients on any medications other than the study drug (Lansoprazole or placebo), Amoxicillin®, and acetaminophen with or without codeine

• An underlying medical condition which would necessitate an alteration in the anesthetic regimen

• Patients allergic to any of the medications in the protocol

• History of chronic tonsillitis

• History of chronic pain conditions

• History of active gastro-esophageal reflux disease

• Surgery in addition to tonsillectomy/adenotonsillectomy (except for myringotomy)

• Cognitive/developmental disorders

• Inability to use a self-report pain scale

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Boston	Boston	Massachusetts	United States	02115
2	Childrens Hospital Boston	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Boston Children's Hospital

Investigators

• Principal Investigator: Manali Amin, MD, Children's Hosptial Boston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manali Amin, Instructor, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT00472186
• Other Study ID Numbers: 06-11-0513
• First Posted: May 11, 2007
• Last Update Posted: Dec 6, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Manali Amin, Instructor, Boston Children's Hospital: Tonsillectomy; Pain
• Additional relevant MeSH terms: Lansoprazole; Dexlansoprazole

Study Results

Participant Flow

Pre-assignment Detail	The study was terminated due to low recruitment, since only one participant returned logbooks with data there are concerns with confidentiality therefore no data is being reported.

Arm/Group Title	1: Post-operative Administration of Lansoprazole	2: Placebo
Arm/Group Description	Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.	Placebo: Placebo will also be administered based on weight.
Period Title: Overall Study
STARTED	2	0
COMPLETED	1	0
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	1: Post-operative Administration of Lansoprazole	2: Placebo	Total
Arm/Group Description	Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.	Placebo: Placebo will also be administered based on weight.	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

The study was terminated due to low recruitment, since only one participant returned logbooks with data there are concerns with confidentiality therefore no data is being reported.

Arm/Group Title	1: Post-operative Administration of Lansoprazole	2: Placebo
Arm/Group Description	Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.	Placebo: Placebo will also be administered based on weight.
Measure Participants	0	0

2. Secondary Outcome

Title	The Secondary Outcomes Are the Number of Days to be Free of Pain, the Number of Days to Return to Normal Activity Levels and the Number of Days to Return to Normal Fluid Intake.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

The study was terminated due to low recruitment, since only one participant returned logbooks with data there are concerns with confidentiality therefore no data is being reported.

Arm/Group Title	Lansoprazole	Placebo
Arm/Group Description	Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.	Placebo: Placebo will also be administered based on weight.
Measure Participants	0	0

Adverse Events

Time Frame	The study was terminated due to low recruitment, since only one participant returned logbooks with data there are concerns with confidentiality therefore no data is being reported.
Adverse Event Reporting Description	The study was terminated due to low recruitment, since only one participant returned logbooks with data there are concerns with confidentiality therefore no data is being reported.
Arm/Group Title	1: Post-operative Administration of Lansoprazole		2: Placebo
Arm/Group Description	Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.		Placebo: Placebo will also be administered based on weight.
All Cause Mortality
	1: Post-operative Administration of Lansoprazole		2: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	1: Post-operative Administration of Lansoprazole		2: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	1: Post-operative Administration of Lansoprazole		2: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.