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Trial Outcomes & Findings for The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain (NCT NCT00472186)

NCT ID: NCT00472186

Last Updated: 2021-12-06

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

2 weeks

Results posted on

2021-12-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure
1: Post-operative Administration of Lansoprazole
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.
2: Placebo
Placebo: Placebo will also be administered based on weight.
Overall Study
STARTED
2
0
Overall Study
COMPLETED
1
0
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
1: Post-operative Administration of Lansoprazole
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.
2: Placebo
Placebo: Placebo will also be administered based on weight.
Overall Study
Study was terminated due to poor compliance with returning logbooks by families.
1
0

Baseline Characteristics

The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 2 weeks

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: 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.

Outcome measures

Outcome data not reported

Adverse Events

1: Post-operative Administration of Lansoprazole

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

2: Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manali Amin, MD

Dupage Chidlren's ENT & Allergy

Phone: 630-785-0367

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place